Hair implants comprising enhanced anchoring and medical safety features

ABSTRACT

A hair implant suitable for subcutaneous implantation is provided having an anchor comprising an anchor body, and at least one collagen receiving structure selected from the group consisting of at least one tunnel disposed through the anchor body and an external surface feature of the anchor body. The anchor further comprises at least one hair strand projecting from a distal end of the anchor body, wherein the at least one collagen receiving structure is configured to support collagen ligature growth after subcutaneous implantation of the hair implant so as to anchor the anchor to a hair implant recipient, and the collagen receiving structure is free of hair.

CROSS-REFERENCE TO RELATED APPLICATIONS

This divisional application claims the benefit under 35 U.S.C. § 121 ofU.S. application Ser. No. 16/293,171 filed on Mar. 5, 2019 which in turnis a bypass continuation-in-part application of PCT/US2018/044298, filedon Jul. 30, 2018, and claims priority to U.S. application Ser. No.15/665,369, filed on Jul. 31, 2017 (now U.S. Pat. No. 9,993,334) and toU.S. application Ser. No. 15/718,637 filed on Sep. 28, 2017 (now U.S.Pat. No. 10,105,212), the disclosures of which are incorporated hereinby reference in their entireties. Application Ser. No. 15/718,637 isalso a continuation-in-part application and claims the benefit under 35U.S.C. § 120 of application Ser. No. 15/665,369.

BACKGROUND OF THE INVENTION 1. Field of Invention

This invention relates to the field of hair replacement and moreparticularly to artificial hair implantation and implants.

2. Description of Related Art

For millennia, men and women have been concerned with, ridiculed, andeven suicidal regarding hair loss and the physical and cosmetic impactit makes upon ones' appearance, especially the loss of scalp or facialhair (2-6). Causes of hair loss are numerous including geneticdisorders, genetic inheritance, stress from illness, fever, or physicalactivity, chemotherapy, pulling on hair, curling irons, chemicalprocessing of hair for shaping or coloring etc., aging, poor diet,thyroid disease, ringworm, and many other skin and non-skin diseases toolengthy to list here (1, 7, 52, 90, 91, 114). Treatment for hair loss,including medical and non-medical remedies, have, in most cases, yieldedpoor to fair results (9-14, 51, 53, 59, 92, 93).

Treating hair loss with the currently available options falls short ofmeeting the vast majority of patient expectations, regardless of whetherthe treatment is surgical, medical, or non-medical. Other factors,indirectly associated with not only hair loss, but with how the hairloss treatments look as well, have a far greater impact on one's mentaland physical health. These factors include the psychological, social,and emotional trauma resulting from how one looks and feels after losinghair and the inadequate solutions available. The extent ofpsychological, social, and emotional trauma does not end there. Longterm anxiety and stress can affect one's physical wellbeing as well(2-6).

A hair restoration treatment that meets most if not all of the patient'skey expectations such as the hair looking and feeling natural, providinggood hair density, having a low risk of complications, being affordable,and having very low maintenance, would not only be in great demand butwould also reduce the stress, anxiety, social, and physical impacts onone's life. In addition, a more natural looking hair loss solution wouldengender a very happy, confident, positive attitude and sense ofwellbeing, which, if it can be calculated, would eliminate manyfinancial, social, and emotions burdens carried by those who areafflicted (2-6).

A variety of hair replacement techniques and methods currently exists,such as hair pieces and toupees, hair weaves and extensions, hairimplants, hair transplant surgery, and certain medical treatments thatclaim to grow hair such as minoxidil, finasteride, and the like. All ofthese remedies provide limited success in one aspect or another, andthese limitations not only prevent optimization of expectations butresult in emotional setbacks.

Hair pieces, hair weaves, and hair extensions often do not look and feelnatural, resulting in not only ridicule but also a self-conscious senseor real awareness of how unnatural the hair system may look. Inaddition, these hair pieces or weaves may cause chronic skin irritationresulting in damage and permanent loss of the remaining natural healthyhair.

Hair transplant surgery, another remedy to hair loss (51, 53), is notonly very expensive, but is a very invasive surgical procedure havingnumerous medical risks including infection and scarring of the scalp,hair growth failure, and an unnatural look (26-30, 51, 54, 55, 57, 104,108, 109, 113, 114). Even if the hair transplant surgery is deemed asuccess with no scarring, infection, or hair growth failure, theresults, in most cases, will still yield a very thin low densityappearance (due to limitations of skin healing capacity), an unnaturalappearance at the hairline area due to skin pitting (as a result ofrecipient site surgical skin trauma), and inappropriate diameter of hairfibers placed (the fibers should be fine very thin caliber hair fibersplaced into the hairline for a natural transition—which are difficult toharvest) all of which results in an unnatural look.

Medical therapy of the underlying illness causing hair loss may treatthe condition but typically does not result in the recovery of hair dueto hair follicular organ trauma and death, and thus patients seek a hairrestoration solution (1, 7). There are some medical conditions that haveno medical, non-medical, or surgical treatments such as certain types ofalopecia (9).

Medical pharmacological therapy can prevent or stimulate hair growthdirectly, such as finasteride and minoxidil (10-14, 59). Thesemedications not only perform poorly regarding hair regrowth, but arealso not benign treatments having no risks or side effects. Finasteride,for example, can not only cause a loss in libido, but it can increasethe risk of developing a more aggressive type of prostate cancer.Minoxidil, a topical medication, is problematic because it can grow hairin other parts of the body such as the face, arms, legs and chest, andthis is a side effect that many men and especially women finddisturbing. In addition, minoxidil can lower your blood pressure andcause users to faint or pass out.

Artificial hair implantation, another type of hair restoration method,is currently illegal in the United States, but legal in Europe and othercountries (15). Hair implants are associated with many risk factors suchas pain, scarring, scalp infections, chronic inflammation, and deepscalp abscess and granuloma formation. There are numerous medicalarticles recommending not to perform hair implants due to thesecomplications (16-19, 60, 103).

Hair implants are currently illegal in the United States; the U.S. Foodand Drug Administration (FDA) ruling on this matter has now been inforce for many decades (15). Even though some isolated reports claimsome success with artificial implants (21, 61-65, 87, 116, 117), the FDAbanned the use of this artificial hair implant method due to the manypatient complaints and complications such as infection, scarring,chronic inflammation, and other problems (15-19, 60). Even thoughillegal in the United States, it appears that artificial hairimplantation is legal in many areas of the world, including Asia andEurope. Currently there are two companies that have been manufacturingartificial hairs for implantation, Nido (Japan) (20), and Biofibre(Italy) (21), and have been selling and marketing these artificial hairimplants for decades.

An example of a hair implant is taught in U.S. Pat. No. 5,061,284(Laghi) (117), in which a hair plug consists basically of a human hairon which an artificial follicle is formed. Also, U.S. Pat. No. 3,596,292(Erb) (116) teaches a hair implant structure having an anchoring portionextending below the surface of the skin and into the subcutaneoustissue, comprising tissue-pervious structures in the form ofmicrovelours, microporous polymers, reticulated foam polymers orhydrated hydrogels (See FIG. 14).

A further example a hair implant is disclosed in U.S. Pat. No. 9,492,196(Keren) (87) which teaches an anchor formed with a rough surface and aslit or opening through which hair is inserted so that the bulbous rootend is implanted into the target tissue. The opening of the slit issized to restrain the bulbous end of the hair from passing through.

The three most prominent complications resulting from commerciallyavailable hair implant products are infection, inflammation, andscarring. The reason as to why these complications occur are related tothe type of materials used, the specific design of the materials, andhow (the surgical technique) they are anchored to the skin. If thematerials, design, and techniques were improved, risks and complicationswould decrease dramatically, making artificial hair implantation anacceptable alternative hair restoration solution for the hundreds ofthousands of patients who suffer from hair loss worldwide.

The materials used in the current manufacturing of artificial hairimplants involve primarily natural or artificial hair. Hair, whethernatural or artificial, is a very antigenic reactive substance whenconfronted or seen by the immune system (22, 23). Considering thehyper-reactivity and immune response to the materials currently beingused, there appears to be little to no medical consideration regardingmaterial selection and how to minimize this negative interaction withthe body. When this hair implant is placed deep into the scalp, alengthy portion of the hair is directly in contact and totallyunshielded from the blood or immune system. This deep placement anddirect contact of the hair with the body will dramatically increase thepotential for invoking an intense and chronic inflammatory response,which is the source of chronic inflammation, pain, infection, granulomaformation, and other serious issues.

The current hair implant design is rather rudimentary, once again,reflecting no medical consideration for natural anatomy, physiology,immunology nor the microbiological factors involved. This designpromotes inflammatory interactions with the body and does not provide anappropriate barrier for microbiological (bacterial) protection. Inaddition, there is no hair implant design element even attempting tostop foreign invaders (bacteria) from entering the body which, by havingno barrier as part of the hair implant design, can cause serious acuteand long term chronic infections.

The current hair implant technique involves placement of the artificialhair deep into and under the skin. This deep placement involvestunneling the artificial hair under the skin and then attaching it tothe deep fascia that lies just above the skull, called the GaleaAponeurotica. Looping and mounting the artificial hair into the Galea isthe anchoring mechanism which secures the hair from falling out. Eventhough this is a very secure mounting technique, it does not allow for,once again, medical consideration regarding adverse immune systeminteractions or an appropriate bacterial barrier preventing infection,and thus inflammation and infectious complications will often follow.Keep in mind that this technique, with very deep and specific placementinto fascia type tissue, is limited to the scalp area and does not allowfor hair placement in any other part of the body. In addition, there aremajor problems inherent to this type of mounting technique which involvea high risk of chronic inflammation, abscess formation, severe scarringand granuloma formation, etc. These complications can occur because theimplanted artificial (or natural) hair is not shielded, or is in directcontact with the immune system, nor is there a barrier mechanism toprevent bacterial from entering into the body. In addition, theimplanted hair fiber may fracture or fragment leaving portions of highlyantigenic hair pieces deep in and under the skin resulting in acute andchronic inflammation, potential cyst and granuloma formation, chronicpain and scarring.

Accordingly, it is desired to provide improved artificial hair implantsand hair restoration methods using same. It is further desired toprovide artificial hair implants which provide a natural appearance, areconfigured for secure implantation in the skin, do not elicit anantigenic or inflammatory response, and can be implanted in a variety ofdensities and patterns.

All references cited herein are incorporated herein by reference intheir entireties.

SUMMARY OF THE INVENTION

A first aspect of the invention is a hair implant, comprising: at leasttwo strands comprising at least one of mammalian hair and synthetichair; and an anchor, which: (a) comprises silicone, (b) is configuredfor subcutaneous implantation, (c) comprises a fracture line configuredto facilitate fracturing of the anchor along the fracture line for easeof removal of the implant after subcutaneous implantation, and (d) isconfigured to provide a scaffold for collagen growth after subcutaneousimplantation, wherein at least one of the at least two strands is joinedto the anchor on one side of the fracture line and at least one of theat least two strands is joined to the anchor on an opposite side of thefracture line such that each fragment formed by fracturing the implantcomprises at least one of the at least two strands.

In certain embodiments, the at least two strands are synthetic hairscomprising a filament of a polymer selected from the group consisting ofpolypropylene, polyvinyl chloride, polyamide, polyethylene,polyacrylonitrile, polyvinylidene chloride, polyurethane, polyester andcopolymers thereof.

In certain embodiments, the at least two strands have a diameter from0.01 to 3 mm, or from 0.02 to 0.2 mm.

In certain embodiments, the at least two stands have a length from 1 mmto 500 cm or from 1 cm to 50 cm.

In certain embodiments, the anchor has a largest dimension of 0.1 mm to2.5 mm or 0.1 to 5 mm.

In certain embodiments, the anchor has a diameter that decreases from aproximal end to a distal end thereof.

In certain embodiments, the anchor has a diameter that increases from aproximal end to a distal end thereof.

In certain embodiments, the anchor has a diameter that is substantiallyconstant from a proximal end to a distal end thereof.

In certain embodiments, the anchor has a mid-section concavity that isroughly equidistant from a proximal end to a distal end of the hairimplant.

In certain embodiments, the anchor has an open tunnel on at least one ofthe distal end and the proximal end of the anchor.

In certain embodiments, the anchor has at least one open tunnel, atleast one closed tunnel and at least one bridge between two verticalcomponents.

In certain embodiments, the anchor has an undulation on a distal lateralside thereof, said undulation being effective to inhibit bacterialinfection.

In certain embodiments, the anchor has at least one tunnel configured toreceive and retain collagen ligatures so as to bind the anchor to thehair implant recipient.

In certain embodiments, the anchor consists of silicone.

In certain embodiments, the anchor is free of hinged leaves.

In certain embodiments, the hair implant is free of metal components.

A second aspect of the invention is a hair restoration methodcomprising: inserting a needle into the skin to form an incision;inserting an implant of the invention in the incision such that 0.1-2 mmof a silicone coating on a proximal end of each of the at least twostrands remains: (a) outside the skin, (b) above the epidermis, (c)under the skin, or (d) below the epidermis; and applying an adhesive tothe incision.

In certain embodiments of the method, the incision is made to a depth of2-8 mm.

In certain embodiments of the method, the adhesive is cyanoacrylate.

In certain embodiments of the method, collagen infiltrates tunnels ofthe anchor to form ligatures binding the implant.

In certain embodiments of the method, the implant is inserted in theincision such that 0.1-2 mm of the silicone coating on the proximal endof each of the at least two strands remains outside the skin or abovethe epidermis.

In certain embodiments of the method, the implant is inserted in theincision such that 0.1-2 mm of the silicone coating on the proximal endof each of the at least two strands remains under the skin or below theepidermis.

A third aspect of the invention is a method for manufacturing theimplant of the invention, said method comprising: providing a moldcomprising at least one cavity for forming the anchor; filling the atleast one cavity with a silicone liquid; coating 2-10 mm of a proximalend of the at least one strand with a silicone coating; submersing, inthe silicone liquid, the proximal end of the at least one strand to adepth such that 0.1-2 mm of the silicone coating remains outside of thesilicone liquid in the cavity; curing the silicone liquid to provide asolid product; removing the solid product from the mold; and sterilizingthe solid product so as to provide the implant.

A fourth aspect of the invention is a hair implant, comprising: at leastone strand comprising at least one of mammalian hair and synthetic hair;and an anchor, which: (a) comprises silicone, (b) is configured forsubcutaneous implantation, (c) comprises a fracture line configured tofacilitate fracturing of the anchor along the fracture line for ease ofremoval of the implant after subcutaneous implantation, and (d) isconfigured to provide a scaffold for collagen growth after subcutaneousimplantation, wherein the at least one strand is in an internal hairchamber leading from a first distal orifice to a second distal orificesuch that each end of the at least one strand remains outside theanchor.

A fifth aspect of the invention is a hair implant suitable forsubcutaneous implantation, comprising:

a. a hair strand anchor comprising:

-   -   i. an anchor body;    -   ii. a first hair chamber disposed within said anchor body;    -   iii. a second hair chamber disposed within said anchor body; and    -   iv. at least one tunnel disposed through said anchor body, said        tunnel further disposed in between said first hair chamber and        said second hair chamber, where the tunnel is free of a hair;        and

b. at least one hair strand having a portion thereof retained in atleast one of the hair chambers, wherein said retained portion of hairstrand is further encased by said hair chamber;

wherein said tunnel is configured to support collagen ligature growthafter subcutaneous implantation of the hair implant, wherein said tunnelis configured to receive and retain collagen ligatures that are capableof anchoring said hair strand anchor to a hair implant recipient.

In certain embodiments of the hair implant, said hair strand is a humanhair strand or a synthetic hair strand.

In certain embodiments of the hair implant, said anchor body isconstructed from a biocompatible polymer, silicone, silicone polymer,metal, or metal alloy.

In certain embodiments of the hair implant, at least one end of the hairstrand projects from a distal end of the anchor body.

In certain embodiments of the hair implant, said first hair chamber isfluidly connected to said second hair chamber to form a U-shaped hairchamber, wherein said hair strand is retained in said U-shaped hairchamber such that both ends of said hair strand project from a distalend of the anchor body.

In certain embodiments, the hair implant comprises at least two hairstrands, wherein a proximal end of each hair strand is disposed andencased within one of said hair chambers.

In certain embodiments of the hair implant, the tunnel is an open tunneldisposed through the anchor body at a distal end or a proximal endthereof.

In certain embodiments of the hair implant, the tunnel is a closedtunnel disposed through the anchor body.

In certain embodiments of the hair implant, the anchor body has at leasttwo tunnels disposed therethrough.

In certain embodiments of the hair implant, the at least two tunnels areparallel open tunnels, disposed on opposing ends of the anchor body.

In certain embodiments of the hair implant, the at least two tunnels areparallel closed tunnels disposed through the anchor body.

In certain embodiments of the hair implant, at least one of the tunnelsis an open tunnel disposed on a distal end or a proximal end of theanchor body, and at least one of the tunnels is a closed tunnel disposedthrough the anchor body.

In certain embodiments of the hair implant, the tunnel through theanchor body effectively creates a longitudinal fracture line throughsaid anchor body that intersects the tunnel.

A sixth aspect of the invention is a hair implant suitable forsubcutaneous implantation, comprising:

a. a hair strand anchor comprising:

-   -   i. a first anchor body;    -   ii. a second anchor body; and    -   iii. at least one bridge connecting said first anchor body to        said second anchor body so as to bridge at least one void        between said anchor bodies, said void being free of hair; and

b. at least one hair strand having a portion thereof retained in atleast one of the anchor bodies, wherein said retained portion of hairstrand is further encased by said anchor body;

wherein said bridge connecting said anchor bodies is configured tosupport and retain collagen ligature growth after subcutaneousimplantation of the hair implant, wherein said collagen ligatures areconfigured to anchor said hair strand anchor to a hair implantrecipient.

In certain embodiments of the hair implant, said hair strand is a humanhair strand or a synthetic hair strand.

In certain embodiments of the hair implant, said hair strand anchor isconstructed from a biocompatible polymer, silicone, silicone polymer,metal, or metal alloy.

In certain embodiments of the hair implant, each of said anchor bodieshas a hair chamber disposed therein.

In certain embodiments of the hair implant, the hair implant comprisesat least two hair strands, wherein a proximal end of each hair strand isdisposed and encased within one of said hair chambers.

In certain embodiments of the hair implant, said hair chamber of thefirst anchor body is fluidly connected to said hair chamber of the firstanchor body to form a U-shaped hair chamber, wherein said portion of thehair strand is retained in said U-shaped hair chamber such that bothends of said hair strand project from a distal end of the hair strandanchor.

In certain embodiments of the hair implant, a portion of said U-shapedhair chamber is disposed in said bridge.

A seventh aspect of the invention comprises a method of subcutaneouslyimplanting a hair implant in a hair implant recipient. The methodcomprises:

a. providing any one of the hair strand anchors described herein;

b. applying an adhesive to a portion of a first hair strand;

c. inserting said portion of the first hair strand into the first hairchamber;

d. applying the adhesive to a portion of a second hair strand;

e. inserting said portion of the second hair strand into the second hairchamber; and

f. inserting the hair strand anchor into a subcutaneous tissue of therecipient, thereby invoking a foreign body reaction such that the anchorbecomes encapsulated by collagen and collagen ligature growth isdisposed through the tunnel of the anchor, thus anchoring said hairstrand anchor to the hair implant recipient.

In a first preferred embodiment of a proximal to distal insertionmethod, the hair will not be glued first but will first be inserted intothe proximal orifice of the vertical component hair chamber, then thehair is pushed through until only 6 mm of the proximal end is visible,then glue is added to this 6 mm end, and finally the hair is continuedto be pulled through until completely in the hair chamber.

In a second preferred embodiment of a proximal to distal insertionmethod, the hair will not be glued first but will first be knotted atits proximal end or otherwise treated or handled (e.g., by melting or byaugmenting with a bolus of bonding agent, such as glue) to provide abulbous end smaller than the larger opening of the knot chamber andlarger than the smaller opening of the knot chamber, and then fed intothe proximal opening of the knot chamber until only about 6 mm of theproximal end of the hair is visible. Glue is then applied to this 6 mmend (which will contain the knots), and then the hair is continued to befed through the hair chamber until reaches the most distal end of theknot chamber.

In certain embodiments of the hair implant, said at least one voideffectively creates a longitudinal fracture line through said hairstrand anchor that intersects said bridge.

In certain embodiments, the hair implant further comprises at least asecond bridge connecting said first anchor body to said second anchorbody, and bridging at least one void between said anchor bodies.

In certain embodiments of the hair implant, said second bridge isparallel to the first bridge.

An eighth aspect of the invention is an anchor comprising: (a) a firsthair chamber configured to receive at least one hair strand; (b) asecond hair chamber configured to receive at least one hair strand; and(c) at least one tunnel disposed through said anchor between the firsthair chamber and the second hair chamber, wherein: (i) the anchor isconfigured for subcutaneous implantation with at least one hair strandfixed in at least one of the first hair chamber and the second hairchamber; (ii) the tunnel is configured to support collagen ligaturegrowth after subcutaneous implantation by receiving and retainingcollagen ligatures that are capable of anchoring the anchor to a hairimplant recipient.

In certain embodiments of the anchor, at least one tunnel defines alongitudinal fracture line through the anchor that intersects thetunnel, such that the anchor is configured to fracture along thefracture line upon application of sufficient force to facilitate removalof the anchor.

One of the unique and inventive technical features of the presentinvention is the tunnel, or void, being located interior (e.g., middle)of the anchor between the hair chambers, which allows for thesurrounding anchor body around the tunnel to protect the tunnel fromfracturing into multiple pieces, unlike the porous mesh of Erb (116).For instance, the porous mesh of Erb has holes that are not surroundedby a substantial anchor body, and the thin walls between the pores wouldbe vulnerable to fragmentation into multiple pieces. Further still, ifthe tunnel were to fragment, despite the thick surrounding anchor body,the tunnel will fragment in a defined way as to be right down the middlebetween the two hair chambers.

A ninth aspect of the invention is an anchor comprising (a) a hairstrand anchor comprising: (i) an anchor body; (ii) a hair chamberdisposed within the anchor body; and (iii) at least one tunnel disposedthrough the anchor body; and (b) at least one hair strand having aportion thereof retained in and encased by the hair chamber; wherein theat least one tunnel is configured to support collagen ligature growthafter subcutaneous implantation of the hair implant, wherein the atleast one tunnel is configured to receive and retain collagen ligaturesthat are capable of anchoring the hair strand anchor to a hair implantrecipient.

In certain embodiments of the anchor, a single closed tunnel is disposedthrough the anchor body and adjacent a proximal end thereof; and asingle hair chamber is positioned along a central longitudinal axis ofthe hair implant.

In certain embodiments of the anchor, a single open tunnel is disposedthrough the anchor body at a proximal end thereof; and a plurality ofclosed tunnels is also disposed through the anchor body.

In certain embodiments of the anchor, the plurality of closed tunnelsare two parallel closed tunnels.

In certain embodiments of the anchor, the single open tunnel ispositioned between the parallel closed tunnels.

A tenth aspect of the invention is a hair implant suitable forsubcutaneous implantation, comprising: (a) an anchor comprising: (i) ananchor body; and (ii) at least one collagen receiving structure selectedfrom the group consisting of a tunnel disposed through the anchor bodyand an external surface feature of the anchor body; and (b) at least onehair strand projecting from a distal end of the anchor body, wherein theat least one collagen receiving structure is configured to supportcollagen ligature growth after subcutaneous implantation of the hairimplant so as to anchor the anchor to a hair implant recipient.

In certain embodiments of the hair implant, the at least one hair strandhas a diameter from 0.02 to 0.2 mm.

In certain embodiments of the hair implant, the at least one hair strandhas a length from 1 cm to 50 cm.

In certain embodiments of the hair implant, the at least one hair strandis a human hair strand or a synthetic hair strand.

In certain embodiments of the hair implant, the at least one hair strandis a synthetic hair comprising polymer filaments selected from the groupconsisting of polypropylene, polyvinyl chloride, polyamide,polyethylene, polyacrylonitrile, polyvinylidene chloride, polyurethane,polyester and copolymers thereof.

In certain embodiments of the hair implant, the anchor has a largestdimension of 0.1 to 2.5 mm.

In certain embodiments of the hair implant, the anchor body comprises abiocompatible polymer, silicone, a silicone polymer, a metal or a metalalloy.

In certain embodiments of the hair implant, the anchor consists ofsilicone.

In certain embodiments of the hair implant, the anchor is free of hingedleaves.

In certain embodiments of the hair implant, the hair implant is free ofmetal components.

In certain embodiments of the hair implant, a retained portion of the atleast one hair strand is retained in an internal hair chamber of theanchor body.

In certain embodiments of the hair implant, the internal hair chamberleads from a first distal orifice to a second distal orifice such thatboth ends of the at least one hair strand project from the distal end ofthe anchor body.

In certain embodiments of the hair implant, a proximal end of the atleast one hair strand is disposed and encased within the internal hairchamber, and a distal end of the at least one hair strand projects fromthe distal end of the anchor body.

In certain embodiments, the hair implant is unitary in structure.

In certain embodiments of the hair implant, the at least one collagenreceiving structure comprises at least one tunnel.

In certain embodiments of the hair implant, the at least one tunnelcomprises an open tunnel disposed through the anchor body at a distalend or a proximal end thereof.

In certain embodiments of the hair implant, the at least one tunnelcomprises a closed tunnel disposed through the anchor body.

In certain embodiments of the hair implant, the anchor body has at leasttwo tunnels disposed therethrough.

In certain embodiments of the hair implant, the at least two tunnelscomprise parallel open tunnels disposed on opposing ends of the anchorbody.

In certain embodiments of the hair implant, the at least two tunnelscomprise parallel closed tunnels disposed through the anchor body.

In certain embodiments of the hair implant, at least one of the tunnelsis an open tunnel disposed on a distal end or a proximal end of theanchor body, and at least one of the tunnels is a closed tunnel disposedthrough the anchor body.

In certain embodiments of the hair implant, the at least one tunneldefines a longitudinal fracture line through the anchor body thatintersects the at least one tunnel.

In certain embodiments of the hair implant, the anchor has an undulationon a distal lateral side thereof, said undulation being effective toinhibit bacterial infection.

In certain embodiments of the hair implant, the anchor has a diameterthat decreases from a proximal end to a distal end thereof.

In certain embodiments of the hair implant, the anchor has a diameterthat increases from a proximal end to a distal end thereof.

In certain embodiments of the hair implant, the anchor has a diameterthat is substantially constant from a proximal end to a distal endthereof.

In certain embodiments of the hair implant, the anchor has a mid-sectionconcavity that is roughly equidistant from a proximal end to a distalend of the hair implant.

In certain embodiments of the hair implant: (a) the anchor comprisessilicone; (b) the anchor is configured for subcutaneous implantation;(c) the anchor comprises a fracture line configured to facilitatefracturing of the anchor along the fracture line for ease of removal ofthe implant after subcutaneous implantation; (d) the anchor isconfigured to provide a scaffold for collagen growth after subcutaneousimplantation; (e) the hair implant comprises at least two hair strands;and (f) at least one of the at least two hair strands is joined to theanchor on one side of the fracture line and at least one of the at leasttwo hair strands is joined to the anchor on an opposite side of thefracture line such that each fragment formed by fracturing the implantcomprises at least one of the at least two hair strands.

In certain embodiments of the hair implant, the anchor body comprises afirst internal hair chamber and a second internal hair chamber, the atleast one collagen receiving structure comprises at least one tunneldisposed between the first internal hair chamber and the second internalhair chamber, the at least one tunnel is free of hair, the hair implantcomprises a plurality of hair strands, the first internal hair chamberencases a retained portion of at least a first one of the hair strandsand the second internal hair chamber encases a retained portion of atleast second one of the hair strands.

In certain embodiments of the hair implant, the at least one collagenreceiving structure comprises at least one tunnel, the anchor comprisesa first anchor body and a second anchor body connected by at least onebridge that spans the at least one tunnel, the at least one tunnel isfree of hair, the first anchor body comprises a first internal hairchamber, the second anchor body comprises a second internal hairchamber, the hair implant comprises a plurality of hair strands, thefirst internal hair chamber encases a retained portion of at least afirst one of the hair strands and the second internal hair chamberencases a retained portion of at least a second one of the hair strands.

In certain embodiments of the hair implant: (a) the at least onecollagen receiving structure comprises at least one tunnel; (b) the atleast one tunnel is free of hair; and (c) the anchor body comprises afirst tapered side, a second tapered side, a first internal hair chamberdisposed within the anchor body parallel to the first tapered side andencasing a retained portion of at least one first hair strand, a secondinternal hair chamber disposed within the anchor body parallel to thesecond tapered side and encasing a retained portion of at least onesecond hair strand.

In certain embodiments of the hair implant: (a) the at least onecollagen receiving structure comprises at least one tunnel; (b) the atleast one tunnel is free of hair; and (c) the anchor body comprises afirst vertical side, a second vertical side, a first internal hairchamber disposed within the anchor body parallel to the first verticalside and encasing a retained portion of at least one first hair strand,a second internal hair chamber disposed within the anchor body parallelto the second vertical side and encasing a retained portion of at leastone second hair strand.

In certain embodiments of the hair implant, a retained portion of the atleast one hair strand is retained in a single internal hair chamberpositioned along a central longitudinal axis of the hair implant, andthe at least one collage receiving structure comprises two parallelclosed tunnels at a distal end of the hair implant.

In certain embodiments of the hair implant, a retained portion of the atleast one hair strand is retained in a single internal hair chamberpositioned along a central longitudinal axis of the hair implant, andwherein the at least one collage receiving structure comprises oneclosed tunnel at a distal end of the hair implant.

In certain embodiments of the hair implant, the at least one bridgecomprises four parallel bridges which are oval-shaped in cross-sectionand span three closed tunnels and two open tunnels.

In certain embodiments, the hair implant comprises five parallel closedtunnels disposed through the anchor body along a central longitudinalaxis, wherein: (a) the tunnels are flanked by the first internal hairchamber and the second internal hair chamber; (b) the three uppermosttunnels are substantially identical in size; (c) the two lowermosttunnels are larger than the three uppermost tunnels; (d) the lowesttunnel is the largest tunnel; and (e) the anchor has a diameter thatdecreases from a proximal end to a distal end thereof.

In certain embodiments of the hair implant, the anchor body comprises afirst internal hair chamber and a second internal hair chamber, the atleast one collagen receiving structure comprises an external surfacefeature of the anchor body comprising three protrusions on each of twoopposite sides of the hair implant, the hair implant comprises aplurality of hair strands, the first internal hair chamber encases aretained portion of at least a first one of the hair strands and thesecond internal hair chamber encases a retained portion of at leastsecond one of the hair strands.

In certain embodiments of the hair implant, the anchor body has acruciform configuration comprising two hair element arms and two anchorarms, a first hair element arm comprises a first internal hair chamber,a second hair element arm comprises a second internal hair chamber, thehair implant comprises a plurality of hair strands, the first internalhair chamber encases a retained portion of at least a first one of thehair strands and the second internal hair chamber encases a retainedportion of at least second one of the hair strands.

In certain embodiments of the hair implant, the anchor body has aninverted Y-shaped configuration comprising one hair element arm and twoanchor arms, a first internal hair chamber in the hair element arm, asecond internal hair chamber in the hair element arm, the hair implantcomprises a plurality of hair strands, the first internal hair chamberencases a retained portion of at least a first one of the hair strandsand the second internal hair chamber encases a retained portion of atleast second one of the hair strands.

In certain embodiments of the hair implant, the anchor body comprises afirst internal hair chamber and a second internal hair chamber, the atleast one collagen receiving structure comprises an external surfacefeature of the anchor body comprising a plurality of protrusions on aproximal end of the anchor body that curve upward toward the distal endof the anchor body, the hair implant comprises a plurality of hairstrands, the first internal hair chamber encases a retained portion ofat least a first one of the hair strands and the second internal hairchamber encases a retained portion of at least second one of the hairstrands.

In certain embodiments of the hair implant, the anchor body comprises afirst internal hair chamber and a second internal hair chamber, the atleast one collagen receiving structure comprises an external surfacefeature of the anchor body comprising a plurality of cup-shapedprotrusions encircling the anchor body with concavities opened towardthe distal end of the anchor body, the hair implant comprises aplurality of hair strands, the first internal hair chamber encases aretained portion of at least a first one of the hair strands and thesecond internal hair chamber encases a retained portion of at leastsecond one of the hair strands.

In certain embodiments of the hair implant, the anchor body comprises afirst internal hair chamber and a second internal hair chamber, the atleast one collagen receiving structure comprises an external surfacefeature of the anchor body comprising a thread helically encircling theanchor body, the hair implant comprises a plurality of hair strands, thefirst internal hair chamber encases a retained portion of at least afirst one of the hair strands and the second internal hair chamberencases a retained portion of at least second one of the hair strands.

In certain embodiments of the hair implant, the anchor body has a cuboidconfiguration, the anchor body comprises at least four internal hairchambers each of which contains a retained portion of at least one hairtherein, the at least one collage receiving structure comprises at leastone tunnel running lengthwise between hair chambers and at least onetunnel running widthwise between hair chambers, and the tunnels are freeof hair.

In certain embodiments of the hair implant, the anchor body has an ovoidconfiguration, the anchor body comprises more than two internal hairchambers, the at least one collagen receiving structure comprises atleast one tunnel disposed at a proximal end of the anchor body, the atleast one tunnel is free of hair, and the hair implant comprises aplurality of hair strands with retained portions thereof being encasedin the hair chambers.

In certain embodiments of the hair implant, the at least one collagenreceiving structure comprises at least one closed tunnel and at leastone open tunnel, which are disposed in parallel through the anchor bodyalong a central longitudinal axis, and wherein 1-5 hair strands aredisposed at a distal end of the hair implant.

In certain embodiments of the hair implant, the anchor body is generallycylindrical in shape, wherein a top portion tapers from a largerdiameter to a smaller diameter. The anchor body may comprise twovertical columns of closed tunnels and a pair of open tunnels at abottom of the anchor body.

In certain embodiments of the hair implant, the anchor body is generallycylindrical in shape, wherein a top portion tapers from a largerdiameter to a smaller diameter and includes a bulbous, convex baseportion, wherein a top of the base portion and a bottom of the baseportion have substantially the same diameter. The anchor body maycomprise two vertical columns of closed tunnels and a pair of opentunnels at a bottom of the anchor body.

In certain embodiment of the hair implant, the anchor body is agenerally a rectangular solid in shape, and may include a bulbous, baseportion having flat sides and edges having smoothly rounded radii. Theanchor body may comprise two vertical columns of closed tunnels and apair of open tunnels at a bottom of the anchor body.

An eleventh aspect of the invention is a hair restoration methodcomprising: (1) forming an incision in the skin; (2) inserting animplant of the invention in the incision such that 0.1-2 mm of asilicone coating on a proximal end of each of the at least two hairstrands remains: (a) outside the skin, (b) above the epidermis, (c)under the skin, or (d) below the epidermis; and (3) applying an adhesiveto the incision.

In certain embodiments of the hair restoration method, the incision ismade to a depth of 2-8 mm.

In certain embodiments of the hair restoration method, the adhesive iscyanoacrylate.

In certain embodiments of the hair restoration method, collageninfiltrates tunnels of the anchor to form ligatures binding the implant.

In certain embodiments of the hair restoration method, the implant isinserted in the incision such that 0.1-2 mm of the silicone coating onthe proximal end of each of the at least two hair strands remainsoutside the skin or above the epidermis.

In certain embodiments of the hair restoration method, the implant isinserted in the incision such that 0.1-2 mm of the silicone coating onthe proximal end of each of the at least two hair strands remains underthe skin or below the epidermis.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

The invention will be described in conjunction with the followingdrawings in which like reference numerals designate like elements andwherein:

FIG. 1 is a front perspective view of an embodiment of an implant of theinvention;

FIGS. 2A, 2B and 2C are front views of three other embodiments of animplant of the invention;

FIGS. 3A, 3B, 3C and 3D show front views of four embodiments of anchorsof the invention;

FIGS. 4A, 4B and 4C show front views of three other embodiments ofanchors of the invention;

FIGS. 5A, 5B, 5C and 5D show front views of four other embodiments ofanchors of the invention;

FIGS. 6A, 6B, 6C and 6D show front views of four other embodiments ofimplants of the invention;

FIG. 7 is a front view of another embodiment of an anchor of theinvention;

FIG. 8 is a top schematic view of an embodiment of the invention whereinimplants are placed in the scalp of a patient in a regular spaced apartmanner defined by a grid;

FIG. 9 is a front perspective view of another embodiment of an anchor ofthe invention;

FIGS. 10A and 10B are front perspective views of additional embodimentsof an implant of the invention;

FIG. 11 is a front perspective view of another embodiment of an implantof the invention;

FIG. 12 is a schematic view of a scalp not in need of hair implantation;

FIG. 13 is a schematic cross-section of skin showing the natural anatomyof hair follicles and follicular units;

FIG. 14 is a table showing a summary of an embodiment of the presentinvention compared to the prior art;

FIG. 15A is a perspective view of another implant anchor embodimentusing a single centralized internal hair chamber and two proximal ends;

FIG. 15B is a top view of the embodiment of FIG. 15A;

FIG. 15C is a cross-sectional view of the implant anchor of FIG. 15Ataken along line 15C-15C of FIG. 15B;

FIG. 15D is bottom view of the implant anchor of FIG. 15A taken alongline 15D-15D of FIG. 15A;

FIG. 15E is a side view of the implant anchor of FIG. 15A with a hairstrand shown positioned in the internal channel;

FIG. 16A is a perspective view of another implant anchor embodimentusing a single centralized internal hair chamber and a single proximalend;

FIG. 16B is a top view of the embodiment of FIG. 16A;

FIG. 16C is a cross-sectional view of the implant anchor of FIG. 16Ataken along line 16C-16C of FIG. 16B;

FIG. 16D is side view of the implant anchor of FIG. 16A;

FIG. 17A is a perspective view of another variation of the implantanchor having three closed tunnels and respective open tunnels at theproximal and distal ends thereof;

FIG. 17B is a top view of the implant of FIG. 17A;

FIG. 17C is a cross-sectional view of the implant taken along line17C-17C of FIG. 17B;

FIG. 17D is a cross-sectional view of the implant taken along line17D-17D of FIG. 17B;

FIG. 18 is a perspective view of a further variation of the implantanchor of the present invention having two hair chambers and having aplurality of closed tunnels but no open tunnels;

FIG. 19 is a perspective view of another embodiment of an implant anchorof the invention, having a “tree-like” formation with upwardly-sweptprotrusions;

FIG. 20 is a perspective view of another embodiment of an anchor of theinvention, having a “tree-like” formation with lateral protrusions;

FIG. 21 is a perspective view of another embodiment of an anchor of theinvention, having a “tree-like” formation with downwardly-sweptprotrusions;

FIG. 22A is a front view of another embodiment of an implant anchor ofthe invention, having a cruciform configuration;

FIG. 22B is a partial perspective view of the implant anchor of FIG. 22Ataken along line 22B-22B of FIG. 22A;

FIG. 23 is a front view of another embodiment of an anchor of theinvention, having an inverted “Y-shape” configuration;

FIG. 24 is a perspective view of another embodiment of an implant anchorof the invention, having a “barbed” configuration;

FIG. 25 is a perspective view of another embodiment of an implant anchorof the invention, having a plurality of “cup-shaped” structures alongthe anchor body;

FIG. 26 is a perspective view of another embodiment of an implant anchorof the invention, having a helix or “screw” type structure around theanchor body;

FIG. 27 is a perspective view of another embodiment of an implant anchorof the invention, having a racket-shaped configuration;

FIG. 28 is a perspective view of another embodiment of an implant anchorof the invention, having a “bar-like” configuration;

FIG. 29 is a front view of another embodiment of an implant anchor ofthe invention, having an ovoid or egg-shaped configuration;

FIG. 30 is a front view of an embodiment of a unitary implant of theinvention, wherein the hair element and the anchor body are formed fromthe same material;

FIG. 31 is a front view of another embodiment of a unitary implant ofthe invention wherein the hair elements and the anchor body are formedfrom the same material;

FIG. 32 is a front view of another embodiment of an implant of theinvention wherein the plurality of hair elements forms or attaches to astyled hair bundle construction;

FIG. 33 is a front view of another embodiment of a unitary implant ofthe invention wherein ancillary hair elements and optional hair budstructures emerge from the sides of the primary hair elements;

FIG. 34A is an isometric view of another implant embodiment of theinvention using a plurality of internal hair chambers, wherein theanchor body has a generally cylindrical construction;

FIG. 34 B is a cross-sectional view of the implant of FIG. 34A, takenalong lines 34B-34B of FIG. 34A;

FIG. 35A is an isometric view of another implant embodiment of theinvention, using a plurality of internal hair chambers, wherein theanchor body has a generally cylindrical construction and a bulbous“donut” feature at the base of the anchor body;

FIG. 35B is a top, plan view of the implant of FIG. 35A;

FIG. 36 is a partial, isometric view of another implant embodiment ofthe invention, using a plurality of internal hair chambers, wherein theanchor body has a generally cylindrical construction, similar to that ofthe embodiment of FIGS. 34A and 34B, but includes fewer hair chambersand hair elements;

FIG. 37A is a top, front isometric view of another embodiment of animplant of the invention, wherein the anchor body has a generallyrectangular-solid construction and a bulbous base of the anchor body;

FIG. 37B is a bottom isometric view of the implant of FIG. 37A; and

FIG. 37C is a top, plan view of the implant of FIG. 37A.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

The goal of implanting artificial hair into the body is to achieve anatural appearance with minimal to no side effects. Artificial hairimplantation in accordance with the invention achieves this goal byproviding a viable and safe patient option for hair loss restoration,which will meet and exceed the expectations of patients not onlydesiring additional scalp hair but also hair on any part of the bodyincluding facial, limb, torso, and pubic areas as well, without theuntoward effects from prior and current methods.

Observing the natural form of existing living hair follicles and theiranatomy has provided valuable information regarding desirable structuraland functional elements of artificial hair implant materials, design,and placement technique.

Natural hair visibly appears exiting from the skin from the deeperdermal layer. This is a very important observation (57, 86). If oneexamines hair weaves, hair extensions, or similar hair systems, the hairexits from above the skin and often looks not only unnatural but doesnot match the natural hair color or hair density patterns that are foundwith natural hair growth on the sides and back of the scalp. Upon closeinspection of these hair systems, it is possible to see the artificialsubstrate to which the hair is anchored. In addition, the hair systemrequires some type of mechanism for anchoring the substrate to the skin,such as tape, glue, or some type of clip. This type of system is likewearing a thick wooly hat which can be uncomfortable at times regardingheat, sweating, and irritation.

Natural anatomic hair density and patterns will vary according to aperson's age, sex and genetics. Very natural and thick looking hair canbe achieved with hair implantation because unlike hair transplantsurgery, there is an unlimited amount of hair available to implant. Massproduction of the hair implants is possible, unlike natural living hairfollicles. Achieving the appropriate hair density results is alsoaccomplished by utilizing a sleek and narrow implant design which willallow close placement or approximation between each hair implant inaddition to having the capability to add emerging hairs (ancillary hairand bud elements described below) to volumize. The hair implant designpreferably mimics the general size and shape of the natural hairfollicle (88, 89). This issue of achieving high hair densities becomescritical for women and young men because, in a far majority of times,they have very full and dense hair patterns showing no signs of hairloss, hair recess patterns, or any balding patterns whatsoever. Any typeof hair restoration, whether medical, surgical, non-medical, that yieldsa low-density look will result in a sub-optimal look for such patients,which results in disappointment and low self-esteem.

Medical treatment, such as minoxidil or finasteride, is not capable ofsuch success. Hair transplant surgery cannot achieve the density goalsdue to limited “living” hairs to transplant from the donor area, andplacing living hair grafts too close together result in trauma and hairfollicular death. Even with the best medical and surgical efforts, 80 to90 follicular units per square centimeter, which is the natural densityof scalp hair, cannot be achieved (55). Artificial hair, such as hairpieces, weaves, wigs, etc., can achieve the hair density and pattern,but these systems are just too unnatural looking and are veryuncomfortable generating heat, sweat, and, in addition, skin irritation,inflammation and traction alopecia resulting in further natural hairloss (90-93).

Cells in the body, including cells of the skin, have natural attachmentsto each other. These attachments provide not only communication channelsbut protect the body from bacteria entering. These attachmentmechanisms, also called tight junctions, or desmosomes (33-38), providefor hair follicle anchoring, protection from invading bacteria, andprotection from the immune system cells approaching or contacting thehair fiber itself.

The natural flora or microbiological organisms of the skin are numerous.These microorganisms are mostly harmless and provide benefits by immunesystem communication and cooperation in assisting in the defense of thebody. However, these living quarters are limited by the natural physicalbarriers present in the skin. The structural anchoring and physicalbarrier mechanisms of the skin, including the hair follicle and itsclose association to the surrounding skin, glandular elements, anddesmosomal cellular junctions between the cells, and the naturalcollagen layer surrounding the follicles, limit the natural flora of theskin to penetrate the deeper skin layers and blood circulation. (39, 40,41). The natural flora will change under certain circumstances such aswhen hair loss occurs. If there is loss of the hair follicle, and itsanatomic structure which penetrates deep into the skin is no longerpresent, the normal flora will no longer live there. When a hair implantis placed, this follicular anatomy will be re-created and bacteria will,once again, reside in the superficial skin surface area. When the hairimplant forms the outer collagen shell, or collagen envelope from theforeign body reaction, a channel (or slight spacing) between the implantand collagen will exist to a certain distance distally, which will mimicthe natural follicular anatomy with its natural flora to some degree.With the formation of the collagen envelope, a strong physical barrierwill exist to eliminate bacterial entrance into deeper layers of theskin and into the blood or lymphatic circulation. This type ofcollagenous barrier is the very same barrier found in the normal anatomyand histology of the natural hair follicle (89).

Natural hair fibers are known to be antigenic and very reactive andhighly inflammatory when they are exposed to the immune system. Acollagen envelope surrounding the natural hair follicle prevents theimmune system from “seeing” and attacking or killing the living hairfollicle organ (30, 42, 43, 44). When the hair or hair follicle is foundout of place, and is outside of the natural envelope, such as when thereis ingrown hair for example, the hair encounters the immune system.Ingrown hair invokes a foreign body giant cell reaction (cells involvedin the foreign body reaction) whereby the immune system attempts toencapsulate the hair or hair particles with collagen (45,46). This isthe very reaction that will be exploited in a positive fashion to directand form a collagen envelop around the hair implant of the invention.

There are about 100,000 hairs on the human scalp, and about 5 million onthe human body. There are about 120 square inches of hair bearing skinon the scalp. Each square inch, or 6.4 square centimeters, comprisesabout 833 hairs, or about 130 hairs per square centimeter. See FIG. 12.

Hair loss is not perceived or observed until about 50% is lost. Theultimate goal in hair restoration is to achieve the appearance of a fullhead of hair, which can be achieved by providing only 50% of the normalquantity of hair per unit area. The invention can provide the appearanceof a full head of hair or something less for those whose hairrestoration goals are more modest.

Assuming total hair loss from the human scalp, replacement of 50% of theoriginal quantity requires the implantation of 65 hairs per squarecentimeter. The invention preferably enables implantation of up to 65 orup to 100 hairs per square centimeter. In embodiments of the inventioncomprising emergent hairs, hair density can range up to about 200 hairsper square centimeter. This is greater than the required 65 hairs, butallows for hair loss over time. The extra density will maintain theappearance of a full head of hair for a greater length of time betweenhair implant sessions.

Upon examining the scalp, it will be observed that most hair folliclesnaturally group close together in clusters, and typically are notisolated as single hair follicles. These natural groupings are termed“follicular units” or FUs. As shown in FIG. 13, follicular units 60typically include 1, 2, 3 or 4 hairs 28. See (52). Hair 28 grows out offollicle 62 within dermis 58 and exits epidermis 56. This aspect ofnatural anatomy has been taken into consideration in the design andmanufacturing of the artificial hair implants.

Hair follicle density and depth into the skin is also observed. Surgicalphotos demonstrate the depth and density of hair follicles (51, 54, 55).

In addition to these key anatomic observations of the natural hairfollicle, there are other functional elements such as sensory nerves,blood vessels feeding the hair follicle, sebaceous and other glandularelements involved with certain liquid secretions that are associatedwith the natural living hair follicle. The absence of such functionalelements from artificial hair implants does not impede the goals of verynatural feeling and looking hair.

Thus, there are several features in the natural anatomic design that canbe emulated in the artificial design to meet the patient's goals ofachieving a full or near full complement of naturally feeling andlooking hair. Artificial implants of the invention preferably provideone or more of the following features: (1) the natural look of hairexiting the scalp, (2) natural hair density and pattern, (3) appropriateanchoring of the hair implant to prevent undesirable fall out, and (4)protecting the artificial hair implant from the immune system andpreventing short and long term inflammation.

Hair Implantation: Structure, Function, and New InnovativeConsiderations

Materials

Introduction

Medical grade silicone rubber and similar materials have been used forcosmetic and medical use for decades as major components of implantablemedical devices. These materials have been used in millions of peopleover the last few decades for facial, breast, and other bodyenhancements. These implants have been proven safe for permanentimplantation into the body. Even though safe, it is recognized thatthere is the possibility of the need for future replacement of suchimplants over time. Implant replacement is indicated, for example in thecase of long standing, malformed or ruptured silicone breast implants(and other cosmetic implants), when severe contracture, pain,psychological issues, or an aggressive foreign body reaction withcollagen encapsulation of the medical device results. (66-70, 73-75).

The anchor portion of the implant, with or without any assistance orneed of an additional chemical coating to help provide longevity, willbe in direct contact with the body and immune system. This material willinvoke a foreign body reaction. The foreign body reaction will result inwalling off or encapsulating the implant with collagen. This reactionwill continue until the entire implant is surrounded with collagen. Thisenveloping of collagen around the implant is favorable for many reasons.First, the complete collagen envelope around the implant will shield theimmune system from the implant itself, which is the goal of the foreignbody reaction to any foreign body. Second, the collagen will form achemical bond directly with the implant material resulting in anattachment or implant stabilizing anchoring feature. Third, the collagenformation, over time, will contract, which will add additional anchoringand stabilization of the implant along concave aspects of the implant.Lastly, and most importantly, this collagen envelope is naturally foundin the normal anatomy of the hair follicle, which provides a naturalcollagen barrier for the highly antigenic hair follicle from the immunesystem, and thus, will provide the same function for the hair implant.

The foreign body reaction is the body's response to a foreign bodyinvading or entering the body such as a piece of metal, plastic, orforeign substance. The ultimate goal of this reaction is to protect thebody by quarantine or encapsulating the foreign substance with collagen,and thereby entombing and subsequently rendering this substance harmlessto the body. Once this immune system response has been completed, thisencapsulation reaction will cease.

Considering that the immune system's foreign body reaction results incollagen encapsulation, this mechanism can be exploited and used in aspecial way regarding the hair implant healing and anchoring process.This reaction can assist in producing collagen in a controlled andprecise manner. The desired objectives would be to surround and form anenvelope of collagen around the hair implant, provide anti-bacterialprotection, provide significant anchoring features needed for stabilityand the success of hair implantation, and protect the implant fromfurther immune system reactions, such as chronic inflammation, etc. Theforeign body reaction and the sequence of events will be discussedbelow.

After placement of the hair implants, the body will see that a foreignsubstance has been introduced into the body. The hair implant itself,with the silicone tip or anchor will be exposed or in direct contactwith the body. This direct contact will initiate the very specialbiochemical immune system reaction, the foreign body reaction.

This foreign body reaction is typically seen as the end-stage responseof the inflammatory and wound healing process following implantation ofa medical device or prosthesis. The objective of this special type ofreaction is to wall off or quarantine this foreign substance in aneffort to protect the body. This reaction, which is quite different froma white blood cell response to a bacterial infection, is composed ofvery special cells called macrophages and foreign body giant cells.These cells initiate an inflammatory response resulting in collagenformation which will ultimately surround or wall off the foreign body intotal if possible, essentially entombing it in collagen and rendering itsafe or harmless while remaining in the body. This also results inimmune system dormancy.

This resulting envelope of collagen formation around the implant willprevent a chronic inflammatory reaction by completely shielding it fromthe immune system. This reaction towards the hair implant is desirable.

In addition, the collagen formation will help anchor the hair implant tothe skin by a combination of biochemical reactions and physicalinteractions. The biochemical reaction is the direct attachment of thecollagen to the silicone material.

A physical interaction between the newly formed collagen and the hairimplant anchor will also occur. Considering that, in certainembodiments, the shape of the anchor is concave, the collagen will hugor tighten around the anchor preventing the anchor from release from theskin. Another physical feature of the anchor are tunnels. These tunnelswill allow the collagen to infiltrate the anchor forming a loop ofcollagen which will help bind the implant with a living biologicalligature. The biological collagen ligatures will be one of the mainmechanisms by which the anchor is held in. If the anchor were tofracture along the fracture line, which it is designed to do ifexcessive erosion or stress is placed on the anchor, the collagenligatures will release causing instability of the resulting two parts ofthe anchor. This destabilization permits easy release of the anchor thusprevent fragment retention within the body.

Lastly, the combination of the collagen enveloping and direct physicalanchoring effects result in a tightening effect of the collagen aroundthe anchor, which adds an additional protective feature, preventingbacteria from entering in between the anchor and the collagen envelopedue to the limited space formed there. Now, with the foreign body (theanchor) entombed in collagen, the body's immune system has accomplishedits protective function and will allow the entombed substance to remainwithin the body, without further acute or chronic inflammatoryreactions, for the rest of one's life.

It is critical to note that natural hair follicles have a collagen shellor envelope as well, which is a very important and interesting parallelto not only mention but to emulate. As natural hair fibers aredeveloping embryologically, this protective collagen envelope is seenforming around the hair follicle. This is not by accident but by designbecause without this outer collagen shell, the body would attack thehair follicle thinking it was a foreign body, and destroy it.

Thus, the foreign body reaction is exploited to serve the manyaforementioned hair implant functions and goals such as hair implantanchoring and stability, infection prevention, immune reaction dormancyeliminating chronic inflammatory conditions, and preventing subsequentpain, discomfort and scarring.

Natural Look

Obtaining the natural look of hair exiting the skin at the epidermallevel can be accomplished by using natural (or synthetic) hair fiberstrands, and implanting these fibers in such a fashion as to emulate thenormal hair fiber—epidermal junction anatomy (with no pitting, orunusual anatomic aberrations). The materials needed to accomplish thisare the natural looking hair strands, whether natural or synthetic, and,for simplicity of the discussion, silicone rubber to coat the tip of thehair. The hair tip portion that is coated with silicone rubber will bein direct contact or implanted into the skin itself. The key to anatural hair exit look from the scalp or any hair bearing skin areas, isclosely associated with the type of incision made (discussed in theimplant technique section) and the shape of the silicone implant at theepidermal level (discussed in the design section).

The hair strand(s), whether natural or artificial, can be tailored incolor, shape, length, etc., to the anatomic location and cosmeticdesires and needs of the patient. For example, hair implants for thescalp can be custom designed to be long, short, straight, curly, black,or blonde, etc. Hair implants can also be customized for the eyebrows,pubic, and other areas of the body. See, e.g., Otberg et al. (58).

In embodiments wherein the hair component, whether natural or synthetic,will be coated with another material and then implanted into the skin,the type of hair used is not critical since the hair is not visible tothe body or immune system. Only the coating on the hair will be indirect contact with the skin and subcutaneous tissues or immune system.This optional coating substance, such as medical grade silicone (orother or combination of materials such as an additional outer layer ofpolycarbonate), will be in direct contact with the skin and immunesystem and thereby play a role to not only biochemically bind,physically hold, ligature anchor, to stabilize the implant but also toreduce the oxidation reaction in efforts to preserve the integrity ofthe implant long term from fracture or breakdown.

Materials suitable for the hair component of the inventive implantinclude but are not limited to human hair, animal hair and syntheticpolymers. Non-limiting examples of polymers suitable for synthetic hairinclude one or more of polypropylene, polyvinyl chloride, polyamide,polyethylene, polyacrylonitrile, polyvinylidene chloride, polyurethaneand polyester.

Hair suitable for use in the invention can be straight, tightly curledor loosely curled. Suitable hair can be colored, partially colored oruncolored. The length of the hair fibers is not particularly limited,but suitable hair fibers are preferably at least 5 cm or at least 10 cmor at least 15 cm in length for ease of styling after implantation. Hairmaterials suitable for use in the invention preferably have a diametersimilar to naturally occurring hair, for example, ranging from 0.02 to0.2 mm. The cross-sectional shape of the hair is preferably ellipticalor round, like naturally occurring hair.

Hair Density and Pattern

The anchor preferably has a very narrow design, simulating the actualsize of the natural hair follicle, which enables close placement orapproximation of the hair implants, yielding a greater density of hairsper unit area. The anchor preferably has significant material strengthand durability to withstand pulling forces and oxidation reactions fromthe immune system.

Anchoring of the Hair Implant

The composition of the anchor of the inventive implant plays a majorrole in anchoring of the hair implant; however, there are other majorfactors involved with anchoring such as the shape and internal structureof the implant which will be discussed in the design section. Theimplant material allows for the stimulation of the foreign body reactionto take place, resulting in a collagen envelope forming directly aroundthe implant. This close association will then result in a biochemicalbond between the collagen and the base (i.e., anchor). This bond,whether covalent and/or non-covalent, will provide an anchoring force.Another factor is that the material promotes collagen formation externaland internal to the implant. The anchor preferably comprises tunnels(defined herein as voids of varying dimensions that are configured forinfiltration by host tissues, which include but are not limited topores, grooves and channels) so the foreign body reaction and subsequentcollagen formation can infiltrate the anchor and act as a ligature tohold the implant in place. The material of the anchor is preferably astimulant or collagen growth promoter to encourage this to happen.

The hair implantation prior art teaches that the foreign body reactionis detrimental to implantation and is to be avoided. The instantinvention proceeds contrary to the prior art by encouraging the foreignbody reaction and the resultant formation of a collagen shell orenvelope, and collagen ligatures through the tunnels of the inventiveimplants to anchor them to the scalp or other tissue.

For example, Erb et al. (116) states that the goal is to avoid theforeign body reaction and rejection reactions and Laghi (117) statesthat the foreign body reaction is destructive. Moreover, Erb et al.teaches tissue growth resulting from a non-foreign body reaction, whichis cellular rather than collagenous in nature.

Protecting the Hair Implant from the Immune System

The anchor material assists in protecting the hair implant from immunesystem attacks and oxidation by invoking a foreign body reaction. Theforeign body reaction will allow the body to envelope the hair implantwith a collagen wall and thus “shut down” the immune system since thegoal and final reaction of the foreign body reaction is the quarantiningof the foreign body, which is, in this case, the hair implant itself. Inaddition, a more durable material will resist oxidation from interactionbetween the implant material and the body. This oxidative process maycome from the immune system or local cells releasing certain chemicalscausing this reaction. Lastly, the material preferably allows for alinear fracture (or break) line and eliminates fragmenting. The materialpreferably allows for limited risk of breaking into small pieces.References teaching other implantation methods, such as Erb et al.(116), Laghi (117) and Keren (87), do not recognize the potentialproblem of fragmentation, which may result in device fragment retentionand chronic inflammation, and do not propose a solution to this verysignificant issue.

Hair Implant Safety Features

The materials used for implantable medical devices for human use havebeen studied and have been proven safe and subsequently, have been usedfor over 50 years now. They have been proven safe, of course, but withlimitations. For example breast implants typically last 10 or so years.Even though not permanent, it is acceptable to have them removed andthen replaced. In this line of thinking, hair implants may last 10 ormore years as well, possibly falling out naturally, or simply beingpulled out, etc., however, hair implants can be replaced as well.

Design

Introduction

The design used for the hair implant of the invention involves a certainsize, shape, and internal structure to optimize certain objectives suchas providing secure anchoring, a bacterial barrier, natural andappropriate hair density and pattern placement, and structural integrityof the implant to prevent oxidation and fracture.

Natural Look of Hair Exiting the Scalp

One key design factor for making hair implants to look as natural aspossible is to closely look at how natural hair exits the skin at theepidermal level. The standard or objective in hair implant design is forthe hair implant to exit the scalp with the same or similarepidermal-dermal anatomy of existing hair. Natural hair exiting thescalp (with all of its natural anatomic features) is the ultimate goalto parallel.

The natural hair exiting the epidermis has certain anatomic featuressuch as a narrow diameter exit pore and a certain epidermal slope angleand depth. These natural anatomic characteristics can be emulated byapplying certain design features to the hair implant device. Forexample, by designing the distal end of the hair implant with a tubularshape, minimal diameter, and with an appropriate distal to proximalwidening slope, the hair implant will allow the epidermal openingdiameter and internal sloping to be the same or similar to natural hair.Of course, this epidermal development regarding shaping will occurduring the healing process which will involve the foreign body reactionand epidermal migration.

This natural look of hair exiting the skin is a rare characteristic withmost if not all hair restoration solutions. Wigs and toupees have thehair exiting from above the skin; not very natural at all. Hairtransplant surgery will result in hair exiting from under the skin;however, in most cases, the techniques used typically result in skindamage causing the skin pore to widen and deepen in size, often referredto as a pitting skin look.

Hair Density and Hair Pattern

Design of the anchor will also have an impact on the hair density andpattern and the anchor shape with a general sleek narrow design andcrimped-angled proximal hair strand will assist in achieving thesegoals. The sleek or narrow design, preferably not being wider than300-2500 microns in any particular area, will allow for a greaterplacement of hair implants per unit area, with the goal of achievinghair densities found naturally in any hair bearing area. In certainembodiments, the anchor is sized to fit within a cube of 10 mm×10 mm×10mm.

Hair density and patterns vary among men and women, among the young andold, among race and religions. Natural looking hair, whether theimplants are sparsely or closely placed, can achieve the desired hairdensity and pattern goals for each patient. The high density or “verythick look”, for the young and women, can be achieved by this sleeknarrow design of the hair implant allowing for close approximation ofeach hair implant, resulting in a dense natural hair pattern look.Conversely, a less dense pattern can be placed for elderly men, asdesired.

Closely associated with hair density is hair pattern. This involves hairplacement location and angle of exit. For example, if an elderly manwants to not only have a thinning look but also wants a recedinghairline with a very thin crown area, this is easily achieved by thephysical placement of the implants to the desired skin areas. The angleof exit is a more important feature on the temporal scalp and eyebrowareas. In these locations, the implant will need to angle more acutelythan what is surgically permitted when making the recipient site. Forexample, when making the recipient site, the physician can only insertthe needle/cutting device at a certain angle, which is not acute enough.The need for this acute angle is critical because if the eyebrow hairdoes not grow parallel to the skin, but in an upward and outwardfashion, this will look very unnatural. To achieve this acuteangulation, the hair component itself will be angled or curled.Inserting such a non-linear hair into the silicone portion of theimplant will provide that additional hair exit angulation needed to makethe hair look natural.

Anchoring of the Hair Implant

Design, involving the external and internal shape, will be the mostsignificant aspects regarding hair implant anchoring.

The internal structure consists of one or more tunnels. The foreign bodyreaction will produce collagen along all the surfaces of silicone,including the internal tunnel surfaces. When the collagen forms with thesilicone lined tunnels, it will form a natural loop of collagen, muchlike a natural anchoring stitch or ligature helping to anchor theimplant from being pulled out.

The external structure, which is preferably provided with certainconcave sections, will provide grip points after the collagen hasdeveloped around the implant. When the implant has been surrounded withcollagen, and since there are concave and convex portions, more physicalforce to pull out the hair implant from the skin will be needed becauseof the added drag placed on the implant by the collagen.

Another factor to consider is the collagen contraction that occurs overtime. For example, when silicone breast implants are placed the foreignbody reaction results in a collagen shell around the implant. Thiscollagen shell will contract, or exert a force on the breast implantsover time. This is not favorable for breast implants because it resultsin patient discomfort and pain; however, this is favorable regarding thehair implant device. This collagen formation and contracture force willhelp anchor the hair implant. In addition, this contracture force willprovide a more secure tight barrier between the implant andskin/subcutaneous area, which will prevent bacterial migration.

Protecting the Hair Implant from the Immune System

Referring to FIG. 1, anchor 22 of implant 20 comprises two verticalcomponents (or anchor bodies) 24 joined by a bridge 26, with closedtunnel (or void) 42 above the bridge and open tunnel 44 below thebridge. In this embodiment of the invention, which mimics a naturalfollicular unit having two hairs and two hair follicles, each hair 28 iscontained within an internal hair chamber 30, which has a distal orifice32 and a proximal closure 38 near the proximal end of implant 20. Hair28 exits distal end 34 of implant 20 through distal orifice 32. Inaccordance with a preferred embodiment of the invention, at least onehair 28 is on each side of fracture line 46 (discussed in greater detailbelow), such that there is at least one hair in each of the twofragments resulting from fracturing of implant 20.

Anchor 22 is preferably about 2-8 mm or 3-6 mm in length (i.e., along alongitudinal axis defined by the hair strand(s) within the anchor; topto bottom in the perspective shown in FIG. 1), preferably about 500microns to 2.5 mm in width (i.e., along an axis transverse to thelongitudinal axis; left to right in the perspective shown in FIG. 1) andpreferably about 500 microns to 2.5 mm in depth (i.e., toward the viewerand away from the viewer in the perspective shown in FIG. 1). Thedimensions of the anchor are preferably modified depending on thelocation of hair placement.

For example, scalp hairs penetrate the skin to a depth of approximately6 mm, and eyebrow hairs are generally shorter, about 3-4 mm in length.This depth design not only parallels the natural depth penetration ofthe natural hair follicle but provides additional favorable safetyfeatures. This minimal depth design will allow the body to encapsulateor envelope with collagen and conceal the implant from the immunesystem, unlike prior art hair implant systems. In addition, after thecollagen formation has been completed by the immune system via theforeign body reaction, the interaction between the silicone implant andthe immune system will cease. This is not the case with the prior arthair implant technique, which exposes a relatively very long piece ofvery antigenic hair (whether natural or synthetic) to the immune systemby placing the hair deep into the scalp and looping or connecting thehair to the deep fascia of the scalp, the Galea Aponeurotica. This priorart system results in a state of chronic inflammation with furthersequalae such as infection, scarring, granuloma formation, and pain. Thecollagen enveloping of such a long hair implant, with a knot at the end,and the hair traversing multiple planes of tissue, has proven to bedifficult regarding compete encapsulation of collagen. Without completeencapsulation of the hair implant with collagen, the foreign bodyreaction will continue in perpetuity not allowing immune system to shutdown or remain dormant.

Hair Implant Safety Features

There are two primary concerns with hair implant safety—infection andinflammation.

Infection is caused by living organisms such as bacteria, fungi, andviruses. Living organisms naturally live on the skin surface and in asymbiotic manner (in most cases). If the anatomy of the skin is altered,such as in a skin cut, these bacteria can now enter within the body andcause an infection. Hair implantation will involve a temporary minorneedle puncture, then the hair implant is placed in that puncture, thenhealing will occur. It is important that healing occurs and thatinfection and inflammation do not occur.

Hair implants need to be designed to prevent the downward flow ofmicroorganisms from around the hair implant thus preventing an infectionfrom occurring. Prevention of infection is accomplished by the hairimplant internal and external shape, foreign body reaction and collagenenvelope production, collagen envelope contraction over time,biochemical bonding reaction between the collagen-silicone rubberinterface, distal design, and patient hair and scalp cleanliness. Suchdesign features are found in the natural anatomy of the hair folliclesuch as the collagen envelope, biochemical bonds at the cell interfaceand tight junctions, and distal narrowing.

The external shape, particularly the narrowing of the distal end, willresult in a minimal epidermal opening thus limiting the corridor sizeand exposure to bacteria at the hair implant skin contact areas. Incertain embodiments, there will be a distal initial upward then downwardslope angulation of the device, tilted upwards by 30-45 degrees, whichwill prevent an easy downward flow pathway for bacteria. The epithelialcell growth that will form along the distal end of the implant and jointhe newly formed collagen envelope, will provide additional cellularcontact and proximity to the implant thus limiting bacterial access.

The general anchoring aspects, which involve the external and internalshape of the hair implant, also support the safety element of preventingbacterial entrance by forming a tight approximation between the implantand living tissue, which prevent an entranceway for bacteria.

The cross-sectional shape of the anchor and subcomponents thereof isround or oval in certain embodiments of the invention.

In certain embodiments, the anchors have overall shapes like letters ofthe alphabet. These embodiments (collectively referred to as “theAlphabetical Anchors”) are identified herein with the term “Anchor”followed by the letter that the anchor most resembles (e.g., Anchor A,Anchor H, Anchor W and Anchor V). There will be some variations toanchors corresponding to a designated letter, but the general designatedletter shape will still be evident. Each Alphabetic Anchor comprises atleast one tunnel and at least one bridge.

Preferred Anchor A embodiments are shown in FIGS. 3A, 3B, 3C and 3D.Each embodiment includes two vertical components (or anchor bodies) 24joined by at least one bridge 26 and further includes one open tunnel(or void) 44. The embodiments differ according to the number of closedtunnels they have. The embodiment of FIG. 3A has one closed tunnel 42,the embodiment of FIG. 3B has no closed tunnel, the embodiment of FIG.3C has two closed tunnels 42, and the embodiment of FIG. 3D has threeclosed tunnels 42. The tunnels are substantially centered along thefracture line of the anchors.

Preferred Anchor H embodiments are shown in FIGS. 4A, 4B and 4C. Eachembodiment includes two vertical components 24 joined by at least onebridge 26 and further includes two open tunnels 44 of substantiallysimilar size. The embodiments differ according to the number of closedtunnels they have. The embodiment of FIG. 4A has no closed tunnel, theembodiment of FIG. 4B has one closed tunnel 42, and the embodiment ofFIG. 4C has two closed tunnels 42. The tunnels are substantiallycentered along the fracture line of the anchors.

Preferred Anchor W embodiments are shown in FIGS. 5A, 5B, 5C and 5D.Each embodiment includes two vertical components 24 that diverge fromeach other in a distal direction, are joined by at least one bridge 26and further includes at least one open tunnel 44. The embodiment of FIG.5A has no closed tunnels and two open tunnels 44, the embodiment of FIG.5B has one closed tunnel 42 and two open tunnels 44, the embodiment ofFIG. 5C has two closed tunnels 42 and two open tunnels 44, and theembodiment of FIG. 5D has one open tunnel 44 and no closed tunnels. Thetunnels are substantially centered along the fracture line of theanchors.

Each anchor (alphabetical or otherwise) preferably has two verticalcomponents, at least one horizontal component and at least one tunnel.

The vertical component is the portion of the anchor that will house thehair.

The horizontal component, also called the “bridge”, will be theattachment site connecting adjacent vertical components. Bridges arepreferably 100 microns to 4 mm long and 100 microns to 4 mm in diameter.The number of bridges present, which attach the vertical components, isrelated to the number and type of tunnels formed.

Tunnel sizes preferably range from 100 microns to 6 mm in length and 100microns to 2 mm in diameter.

Referring to the embodiments of FIGS. 2A and 2B, each vertical component24 comprises internal hair chamber 30 having distal orifice 32 at distalend 34 of anchor 22. Internal hair chamber 30 preferably has a diameterfrom 25-250 microns.

The embodiment of FIG. 2A has knot chamber 48 at a proximal end of eachinternal hair chamber 30. Each knot chamber 48 has a diameter greaterthan the respective internal hair chamber 30, such that knot 50 having adiameter greater than the diameter of internal hair chamber 30 isretained within knot chamber and thereby anchors hair 28 to anchor 22.The knot chamber size preferably ranges from 500 microns to 6 mm inlength and 100-750 or 100-500 microns in diameter.

The embodiment of FIG. 2B has proximal orifice 36 at proximal end 40 ofeach internal hair chamber 30.

It is within the scope of the invention for each proximal end of eachinternal hair chamber within an anchor to have a terminus independentlyselected from the group consisting of a knot chamber, a proximal orificeand a proximal closure. It is preferred that each proximal end of eachinternal hair chamber within an anchor have the same type of terminus(e.g., two knot chambers, two proximal orifices or two proximalclosures). In certain embodiments, at least one distal orifice 32 and/orat least one proximal orifice 36 is conical and flares open outwardly.

FIG. 2C shows an embodiment with a “looped” internal hair chamber 30,which passes from one vertical component 24 through bridge 26 to theother vertical component 24. A single hair 28 enters internal hairchamber 30 at one distal orifice 32 and exits the chamber at the otherdistal orifice 32. Placement of hair 28 would preferably involveinserting one strand into one distal orifice 32 and pushing it throughthe looped internal hair chamber to then exit from the other distalorifice 32 until the exposed lengths of hair differ in length by about12 mm. A small amount of glue is then placed on the longer exposedsegment of hair just above the distal orifice, and the glue-bearingsegment of hair is pulled into the internal hair chamber (about 12 mm)such that substantially equal lengths of hair are exposed. The glue isallowed to set, which helps to stabilize or anchor the hair within theinternal hair chamber.

Each vertical component preferably has a round or oval cross-sectionalshape. Adjacent vertical components can combine with bridges to formmany suitable shapes, including the alphabetical shapes discussed above.Thus, for example, adjacent vertical components can be parallel with oneanother and form an “H” shape in combination with a bridge.Alternatively, adjacent vertical components can be angled relative toeach other such that they diverge in a distal direction so as to providea “W” or “V” shape. Anchor A can be provided when the adjacent verticalcomponents are angled relative to each other such that they diverge in aproximal direction.

The vertical components and their bridges form tunnels. A tunnel istermed “open” if it is not completely enclosed along its length, andtermed “closed” if it is open only at the ends thereof.

The external surface of anchor need not be perfectly smooth or linear.Non-limiting examples of external surface variations within the scope ofthe invention are illustrated by FIGS. 6A-6D in the context of an AnchorA embodiment. Variations of the external surface within the scope of theinvention include but are not limited to a vertical component distalupward then downward slope or only a downward slope (undulation 66), avertical component mid-section concavity 52, a vertical componentwidening from distal to proximal (most apparent in FIG. 6A), a verticalcomponent proximal bulbous shape 54, and rounded edges on all aspects ofthe anchor.

Open tunnels 44 are additional examples of external surface features.The open and closed tunnels facilitate a clean fracture of the implantresulting in two parts each including a least one hair. Open tunnelspreferably have a length of 0.5-7.5 mm or 1-5 mm, and a depth from 50microns to 5 mm or from 100 microns to 2 mm.

In certain embodiments, the anchor may have an external concavity 52located at the mid-longitudinal area on both lateral sides (FIG. 6B).

FIG. 7 shows an embodiment comprising concavity 52 and undulation 66.Concavity 52 and undulation 66 can be described in circle diameter andarc degrees. The circle size diameter preferably ranges from 100 micronsto 75 mm or 1 mm to 50 mm, and the arc size preferably ranges from 1degree to 180 degrees.

FIGS. 10A and 10B show alternative embodiments of the implant 20, havingconcavities 52 located at the mid-longitudinal area on both lateralsides, undulations 66 at the distal end of the anchor 22 and three orfour hairs 28. It is preferred that each vertical component 24 containonly one internal hair chamber 30 regardless of the number of hairstherein, such that implant 20 has two internal hair chambers 30, withone on each side of the fracture line (excluding the looped hairembodiment described above and shown in FIG. 2C).

FIG. 9 shows another external surface feature, wherein roundedindentation 68 is formed in distal end 34 of anchor 22 between distalorifices 32. Rounded indentation 68 is preferably a distal sagittalmid-line U-shaped indentation that will not follow the pattern of acircle and arc description.

FIG. 11 shows another embodiment of an implant of the invention, whichcomprises two vertical components 24 joined by bridges 26 and one closedtunnel 42.

FIGS. 15A-15E and 16A-16D depict additional embodiments of the implantanchor 20 that comprises a single internal hair chamber 30 and eithertwo proximal ends 40A/40B (FIGS. 15A-15E) or a single proximal end 40(FIGS. 16A-16D).

As shown most clearly in FIGS. 15A and 15C, the implant anchor 20comprises a single anchor body 24 having a centralized internal hairchamber 30. The lower end of the anchor body 24 comprises an open tunnel44, thereby forming two proximal ends 40A and 40B of the anchor body 24.Adjacent a bridge 26 connecting the two proximal ends 40A/40B at theclosed end of the open tunnel 44 are respective closed parallel tunnels42A and 42B. As can be seen most clearly in FIG. 15B, the outer frontand back surfaces of the anchor 20 comprise a respective connectingsurface 27A and 27B between the sides of the anchor body 24. FIG. 15Ddepicts the two rounded proximal ends 40A and 40B and FIG. 15E depictsone hair strand 28 positioned within the centralized internal hairchamber 30 and protruding from the distal orifice 32 at the distal end34.

FIGS. 16A-16D depict the implant anchor 20 which also uses a singleinternal hair chamber 30 but which comprises a single proximal end 40.As shown most clearly in FIGS. 16A and 16C, the proximal end 40comprises a single closed tunnel 42. FIG. 16C depicts one hair strand 28positioned within the centralized internal hair chamber 30 andprotruding from the distal orifice 32 at the distal end 34.

In accordance with all other implant anchor embodiments, the anchorvariations described in FIGS. 15A-15E and 16A-16D comprise similarmaterials and utilize the open and closed tunnels for supportingcollagen ligature growth after subcutaneous implantation to receive andretain collagen ligatures that are capable of anchoring the hair strandanchor to a hair implant recipient. As is the case with all otherimplant anchor embodiments having tunnels, the open and/or closedtunnels can also define a fracture line as discussed above.

FIGS. 17A-17D depict a further variation of the implant anchor 20 whichuses a pair of internal hair chambers 30 and a plurality of closedparallel tunnels 42 with open parallel tunnels at the distal end 34 andthe proximal end 40. In particular, the implant anchor 20 of FIGS. 17Aand 17C comprises a plurality of closed tunnels 42 (e.g., three closedtunnels), each separated by a bridge 26, and vertically-aligned along acentral portion of the anchor body 24. An open tunnel 44 is present atthe distal end 34 and at the proximal end 40. The bridges 26 comprise anoval-shape as shown most clearly in FIG. 17D. As shown most clearly inFIG. 17C, on each side of a longitudinal anchor body axis, is a hairchamber 30 that is oriented vertically and each chamber 30 has a distalopening 32 at one end as well as a proximal closure 38 at the other end;these vertically-oriented chambers 30 are parallel to the vertical sidewalls shown in FIG. 17C. These vertically-oriented hair chambers 30 arealso referred to as “straight” chambers since if their axis lines wereextended, they would not intersect.

In accordance with all other implant anchor embodiments, the anchorembodiment described in FIGS. 17A-17D comprises similar materials andutilizes the closed tunnels for supporting collagen ligature growthafter subcutaneous implantation to receive and retain collagen ligaturesthat are capable of anchoring the hair strand anchor to a hair implantrecipient. As is the case with all other implant anchor embodimentshaving tunnels, the open and/or closed tunnels can also define afracture line as discussed above.

FIG. 18 depicts a further variation of the implant anchor 20 which usesa pair of internal hair chambers 30 and a plurality of closed paralleltunnels 42 but no open tunnels at the distal end 34 and the proximal end40. In particular, the implant anchor 20 of FIG. 18 comprises aplurality of closed tunnels 42 (e.g., five closed tunnels), eachseparated by a bridge 26, and vertically-aligned along a central portionof the anchor body 24. On each side of a longitudinal anchor body axis,is a hair chamber 30 that is parallel with the side of the hair implant20 and each channel 30 having a distal opening 32 at one end as well asa proximal closure 38 at the other end. These hair chambers 30 are alsoreferred to as “crossed” chambers since if their axis lines wereextended, they would intersect. By way of example only, the upper threeclosed tunnels may be identical in size (e.g., 100 microns in width and200 microns in length) while the lower two tunnels are of larger size,e.g., the fourth closed tunnel 42 from the top may comprise a largersize (e.g., 200 microns in width and 400 microns in length) while thebottom-most closed tunnel 42 may comprise an even larger size, e.g., 300microns in width and 500 microns in length.

Since the implant anchor distal end 34 is smaller in size than theimplant proximal end 40, the sides of the anchor body 24 are notvertical but rather splay or taper outward from the top (i.e., distalend 34) to the bottom (i.e., proximal end 40). As such, the sides of theanchor body are “tilted” or “tapered.” The hair chambers 30, beingparallel to these sides, are therefore “crossed” as described above.

In accordance with all other implant anchor embodiments, the anchorembodiment described in FIG. 18 comprises similar materials and utilizesthe closed tunnels for supporting collagen ligature growth aftersubcutaneous implantation to receive and retain collagen ligatures thatare capable of anchoring the hair strand anchor to a hair implantrecipient. As is the case with all other implant anchor embodimentshaving tunnels, the open and/or closed tunnels can also define afracture line as discussed above.

FIG. 19 depicts a further variation of implant anchor 20 that utilizes apair of internal hair chambers 30 and a plurality of upwardly sweptanchor protrusions 70. In particular, the protrusions 70 emerge from theentire length of the vertical anchor body 24 and project upward at anangle toward the distal end 34 in a “tree-like” fashion. The protrusions70 promote anchoring the hair strand anchor into the scalp of a hairimplant recipient. The anchor possesses a closed tunnel 42 but no opentunnels on the distal end 34 and the proximal end 40. As with all otherembodiments of the invention depicted in the drawings, tunnels,protrusions, tunnels in protrusions and other features can be added toor subtracted from those shown (or not shown) in the drawings to providemodified versions of the depicted embodiments.

FIG. 20 depicts a further variation of implant anchor 20 that alsoutilizes a pair of internal hair chambers 30, a plurality of lateralanchor protrusions 70, and a closed tunnel 42 but no open tunnels on thedistal end 34 and the proximal end 40. In particular, this embodimentfeatures protrusions 70 that project perpendicularly from the anchorbody 24. The protrusions 70 form a “cross-like” pattern because of theway the protrusions 70 intersect with the anchor body 24 of the anchor22.

FIG. 21 depicts a further variation of implant anchor 20 that utilizes apair of internal hair chambers 30, a plurality of downwardly-sweptanchor protrusions 70, and no open or closed tunnels. In particular, theprotrusions 70 emerge from the entire length of the anchor body 24 andproject downward at an angle toward the proximal end 40 in a way thatresembles the fins of a rocket.

In accordance with all other anchor embodiments, the anchor embodimentsdescribed in FIGS. 19-21 comprise similar materials and utilize theclosed tunnels (of FIGS. 19-20) and the protrusions for supportingcollagen ligature growth after subcutaneous implantation to receive andretain collagen ligatures that are capable of anchoring the hair strandanchor to a hair implant recipient. As is the case with all otherimplant anchor embodiments having tunnels, the open and/or closedtunnels can also define a fracture line as discussed above.

FIGS. 22A and 22B depict a further embodiment of implant anchor 20. Inparticular, FIG. 22A depicts an implant having a cruciform configuration22A with two hair element arms 24A and two anchor arms 24B. The hairelement arms 24A comprise respective distal ends 34, and the anchor arms24B comprise respective proximal ends 40. Each hair element arm 24Acomprises internal hair chambers 30 with proximal closures 38, distalorifices 32 and each chamber 30 containing one hair 28. Additionally,the implant anchor contains one closed tunnel 42, which is located at acentral point 43.

FIG. 22B shows a partial perspective view of a distal end 34 of the oneof the hair element arms depicted in FIG. 22A. The cross-sectionillustrates two hairs 28 emerging from the two distal orifices 32.

In accordance with all other anchor embodiments, the anchor embodimentdescribed in FIGS. 22A and 22B comprises similar materials and utilizesthe closed tunnels for supporting collagen ligature growth aftersubcutaneous implantation to receive and retain collagen ligatures thatare capable of anchoring the hair strand anchor to a hair implantrecipient. As is the case with all other implant anchor embodimentshaving tunnels, the open and/or closed tunnels can also define afracture line as discussed above.

FIG. 23 depicts a further embodiment of the implant anchor 20 utilizingan inverted Y-shaped configuration 22B having a single hair element arm24A and two anchor arms 24B. The hair element arm 24A comprises internalhair chambers 30 with proximal closures 38, and orifices on the distalend 34 of the arm 24A. More particularly, the implant anchor 22B isshaped like an inverted “Y.” A closed tunnel 42 is positioned at acentral point where arms 24A and 24B are coupled.

FIG. 24 depicts a perspective view of a further embodiment of theimplant anchor 20 utilizing two internal hair chambers 30 with proximalclosures 38 and distal orifices 32 of the vertical anchor body 24.Beneath the internal hair chambers on the vertical component is a closedtunnel 42 that is flanked by two bridges 26 above and below the closedtunnel. From the proximal end 40 extend four curved protrusions 70 thatcurve upward toward the distal end of the anchor. The entire anchor 22resembles a “fishhook” or barbed anchor body 22C structure, with each ofthe curved protrusions 70 spaced radially, 90 degrees apart from eachother.

FIG. 25 depicts a further embodiment of the implant anchor 20 utilizinga plurality of equally spaced “cup-shaped” structures 71 encircling theanchor body with concavities 52 opened toward the distal end 34 of theanchor body and convexities 72 pointed downward toward the proximal end40 of the anchor body. In particular, the anchor body features twoclosed tunnels 42 that are vertically aligned along a central positionof the anchor body 24. The embodiment also features two internal hairchambers 30 with proximal closures 38 and distal orifices 32.

FIG. 26 depicts a further embodiment of the implant anchor 20 utilizinga vertical anchor body 24 with a “screw-shaped” anchor 22Gconfiguration, wherein the anchor body is helically encircled by athread 76. The pitch ratio of thread 76 is preferably 1 to 5, whereinthe pitch ratio as used herein is defined as the diameter of the anchorbody (not including the thread) divided by the distance along thelongitudinal axis of the anchor body between adjacent crests of thethread (i.e., the height of one complete rotation of the helicalthread). Two internal hair chambers 30 having proximal closures 38emerge from two distal orifices 32 on the anchor. Adjacent the proximalend of the anchor, two bridges 26 are vertically aligned with a closedtunnel 42.

FIG. 27 depicts a further embodiment of the implant anchor 20 utilizingtwo internal hair chambers 30 that emerge from distal orifices 32 andhave proximal closures 38. The anchor 22D resembles a racket andpossesses a plurality of protrusions 70 extending laterally from adistalmost “head” portion of the anchor body with no such protrusions onthe “handle” portion proximal to the “head”. A closed tunnel 42 ispositioned proximal to the internal hair chambers and centrally alignedon the anchor body 24.

In accordance with all other anchor embodiments, the anchor embodimentsdescribed in FIGS. 23-27 comprise similar materials and utilize closedtunnels and projections (i.e., protrusions, undulations, etc.) forsupporting collagen ligature growth after subcutaneous implantation toreceive and retain collagen ligatures that are capable of anchoring thehair strand anchor to a hair implant recipient. As is the case with allother implant anchor embodiments having tunnels, the open and/or closedtunnels can also define a fracture line as discussed above.

FIG. 28 depicts a further embodiment of the implant anchor 20 utilizinga horizontal anchor body 74 having a bar-shaped anchor 22Econfiguration, with multiple distal orifices 32 arranged in a grid-likepattern on the upper surface 34A of the bar-like configuration thatforms the distal end of the implant anchor. In particular, each distalorifice is an opening to an internal hair chamber 30 that contains ahair 28. Four closed tunnels 42 are located between each pair ofadjacent hair chambers 30. Thus, twelve parallel closed tunnels 42 runthrough the full width of the anchor between hair chamber chambers 30and four parallel closed tunnels 42 run through the full length of theanchor between hair chambers 30.

FIG. 29 depicts a further embodiment of the implant anchor 20 having anirregular spherical configuration or ovoid configuration 22F andutilizing a plurality of internal hair chambers 30, each containing onehair 28 that emerges from a distal orifice 32 on the curved distalsurface 34B of the anchor 22. More particularly, the anchor body 24C isovoid or egg-shaped, with the curved distal surface 34B of the anchorbeing wider than the proximal bulbous shape 54. A closed tunnel 42 islocated below proximal closures 38 of the internal hair chambers 30 andis centrally aligned on the anchor body.

In accordance with all other anchor embodiments, the anchor embodimentsdescribed in FIGS. 28-29 comprise similar materials and utilize tunnelsfor supporting collagen ligature growth after subcutaneous implantationto receive and retain collagen ligatures that are capable of anchoringthe hair strand anchor to a hair implant recipient. As is the case withall other implant anchor embodiments having tunnels, the open and/orclosed tunnels can also define a fracture line as discussed above.

FIG. 30 depicts an embodiment of a complete one-piece hair implant unitin which the hair 28 forms the unit's distal end 34. More particularly,the hair element 28 is formed from the same material as the anchor body24 itself. The anchor body 24 comprises a distal end 34 and a proximalend 40. The anchor possesses a plurality of parallel closed tunnels 42,each separated by a bridge 26 and vertically aligned along a centralportion of the anchor body 24. An open tunnel 44 is centrally aligned onthe proximal end.

FIG. 31 depicts a further embodiment of a complete one-piece hairimplant unit in which a plurality of hairs 28 are formed at the distalend 34 of the anchor 22 from the body 24 itself. An open tunnel 44 iscentrally aligned on both the distal end and the proximal end 40.Additionally, a plurality of parallel closed tunnels 42, each separatedby a bridge 26, is vertically aligned along a central portion of theanchor body 24.

FIG. 32 depicts an embodiment of an implant of the invention wherein theanchor 20 comprises a plurality of distal orifices 32 with open tunnels44 between each distal orifice. Each distal orifice comprises a hairelement 28 that emerges from the anchor. In certain embodiments, thehair elements are arranged into a hair bundle construction 78. In otherembodiments, the hair elements are attached to an independently one ormore hairs woven, braided, twisted, rolled, wrapped or otherwiseconstructed through mechanical or chemical means. The hair bundleconstruction may take on a form that includes but is not limited to adreadlock, braid, twist, roll, or interlocking hair formation.

In accordance with all other anchor embodiments, the anchor embodimentdescribed in FIG. 32 comprises similar materials and utilize tunnels forsupporting collagen ligature growth after subcutaneous implantation toreceive and retain collagen ligatures that are capable of anchoring thehair strand anchor to a hair implant recipient. As is the case with allother implant anchor embodiments having tunnels, the open and/or closedtunnels can also define a fracture line as discussed above.

FIG. 33 depicts a further embodiment of a one-piece (or unitary) hairimplant of the invention wherein the anchor 20 comprises a plurality ofprimary hair elements 28 extending from the distal end 34 of theimplant. Each primary hair element is a branched hair containing atleast one ancillary hair element 80. The ancillary hair element stemsoff of the side or trunk of the primary hair element and is attached ina permanent fashion, allowing the primary and ancillary hair elements tobe molded together as one unit. In certain embodiments, each primaryhair element, in addition to containing at least one permanent ancillaryhair element, may also contain at least one hair bud structure 82. Thehair bud structures emerge from the sides or trunks of the primaryand/or secondary (i.e., “emergent”) hair elements and serve as points ofattachment in which additional ancillary hair elements may be added andremoved as desired.

FIGS. 34A and 34B depict a further embodiment of an implant anchor 84having a generally cylindrical shape 86, wherein a top portion 88 tapersfrom a larger diameter 90 to a smaller diameter 92. A plurality ofinternal hair chambers 94 is provided, each containing one hair 96 thatemerges from a distal orifice 98 on the distal surface 100 of the anchor84. Pluralities of closed tunnels 102 and open tunnels 104 in columns105 are located in the anchor body 84. For example, closed tunnels 102may be arranged in two vertical columns 105. A pair of open tunnels 104may be disposed at the bottom of the implant anchor 84.

FIGS. 35A and 35 B depict a further embodiment of an implant anchor 106,similar to that of FIG. 34A and FIG. 34B, having a generally cylindricalshape 108, wherein a top portion 110 tapers from a larger diameter 112to a smaller diameter 114. Again, a plurality of internal hair chambers116 is provided, each containing one hair 118 that emerges from a distalorifice 120 on the distal surface 122 of the anchor 106. Pluralities ofclosed tunnels 124 and open tunnels 126 in columns 128 are located inthe anchor body 106. For example, closed tunnels 124 may be arranged intwo vertical columns 128. A pair of open tunnels 126 may be disposed atthe bottom of the implant anchor 106. Additionally, a bulbous, convexbase portion 130 is provided, wherein a top 132 of the base portion 130and a bottom 134 of the base portion 130 have substantially the samediameter. At least some of the open tunnels 126 and closed tunnels 124may be disposed, or partially disposed, on the convex base portion 130.

FIG. 36 depicts a further embodiment of an implant anchor 136 similar tothat of the embodiments of 34A-34B and 35A-35B (and which can besubstituted for either), showing a lesser plurality of internal hairchambers 138.

Finally, FIGS. 37A-37C depict a further embodiment of an implant anchor140 having a shape that is generally a rectangular solid 142. Thisdesign is a complete one-piece hair implant unit in which a plurality ofhairs 144 are formed at the distal end 146 of the anchor 144 from thebody itself. Closed tunnels 148 are disposed on the sides of rectangularsolid 142 and open tunnels 150 are disposed on the base portion 140. Thebase portion 140 is bulbous, having flat sides 156 and edges 158 havingsmoothly rounded radii.

In accordance with all other anchor embodiments, the anchor embodimentsdescribed in FIGS. 30-40C comprise similar materials and utilize tunnelsfor supporting collagen ligature growth after subcutaneous implantationto receive and retain collagen ligatures that are capable of anchoringthe hair strand anchor to a hair implant recipient. As is the case withall other implant anchor embodiments having tunnels, the open and/orclosed tunnels can also define a fracture line as discussed above.

It is preferred to form such unitary hair implants from materials thatsimulate human hair. Such materials are preferably capable of formingsynthetic hairs having the texture, flexibility, color and dimensionsthat are the same as or substantially similar to those of human hair.

Although the hair portion and the anchor portion of the unitary hairimplants are preferably formed from the same material(s), it is withinthe scope of the invention to modify different portions of the unitaryhair implants differently so as to provide different properties todifferent portions of the implant. For example, dyes and/or pigments canbe selectively applied to change the color of the hair portion of theimplant, and crosslinking agents can be applied to selectively changethe mechanical properties of desired portions of the implant.

It is also within the scope of the invention to form different portionsof the unitary hair implants from different materials where thematerials bond together to provide a substantially seamless connectionbetween the hair portion and the anchor portion of the implant.

Preferred materials for use in preparing the unitary hair implantembodiments of the invention include those materials suitable for use inother anchor and hair embodiments discussed herein.

Non-unitary embodiments of the invention described and shown in thedrawings can also be provided in alternative unitary embodiments.

As noted above, the tunnels and protrusions of the anchor help anchorthe implant within recipient by supporting collagen ligature growthassociated with the foreign body reaction. The protrusions also providemechanical resistance to removal.

The foreign body reaction discussed above also provides protection frombacteria. This collagen envelope or wall will prevent bacteria, whichmay have migrated beyond the distal implant zone, from entering thedermal or subcutaneous space of the skin.

When the foreign body reaction has completed the collagen envelope,there will be a contraction effect over time. This contraction isfavorable because it will tighten the grip of the collagen envelope onthe implant and further limit any gap formation between the implant andliving skin and thus prevent bacterial entrance.

The direct contact between the implant and living skin tissue, calledthe interface, is a bond created by a biochemical reaction. This bondingforce will also help with the attachment of the implant to thesurrounding skin, and thus assist in preventing a corridor for bacterialentrance.

Patient scalp cleanliness is also an important aspect. Keeping thebacterial load or quantity low on the scalp skin, or wherever theimplants are placed will be beneficial in preventing infection.

Another important aspect is the prevention of not only infection butinflammation, not caused by microorganisms. Inflammation is a reactionto the foreign materials placed into the skin, such as the hair and thesilicone rubber component of the hair implant. This inflammatoryreaction will naturally occur when the hair implant is placed, however,it is important to design the implant to yield a self-limitinginflammatory and immune system resulting in chemical and physicalchanges, and this includes hair implants as well. Hair implantoxidation, erosion, fracture and more importantly subsequent implantfragment retention must be considered potential hazards of implantationand thus it is preferred to include in the inventive hair implant safetyfeatures designed to deal with these hazards. If oxidation and erosionof the implant were to occur to a significant degree fragmentation ofthe implant may occur. It is preferable to anticipate this occurrence byincluding in unitary and non-unitary embodiments of the inventive hairimplant a fracture line to facilitate a safe conclusion to the potentialfragmentation and the retention of the fragment. The fracture line is afeature of the implant having reduced resistance to fracturing relativeto the balance of the implant, such that if there is fragmentation itoccurs along the fracture line. FIG. 1 shows an example of a fractureline 24 colinear with a line of tunnels 26. This planned vertical (orlongitudinal) fracture line can facilitate the release of the implantfrom collagen ligatures through tunnels 26, thus allowing for an easierrelease of the now two vertical fragments of the fractured implant. Eachfragment will contain at least one hair and silicone structure. Thefracture line prevents or at least minimizes the likelihood of theformation of random fragments that cannot be removed from the scalp bypulling on hair. The fracture line predisposes the implant to splittinginto two fragments. If fracturing occurs, it is easier for the hairimplant to fall out since it has lost one of its key anchoringmechanisms. Minimal pulling forces will allow the fractured implant tobe completely removed. This safety feature will drastically reduce oreliminate any retained fragments of hair, or portions of the implantwhich, in turn, reduces or eliminates any acute or chronic inflammatoryreactions. If the implant has been totally released, or pulled out, thesubsequent collagen envelope will dissolve over time, and thesubcutaneous architecture will be remodeled. Also, after the implant hasbeen placed into position, and the foreign body reaction completed witha collagen envelope around the structure, if a fragment were to beretained, the collagen envelope structure would provide continuedprotection and serve its function by surrounding the foreign body andprotecting it from the immune system. If an inflammatory reaction wereto occur, the body would attempt to discharge this retained fragment.This reaction would be limited to the very superficial skin surface (asopposed to the deep-rooted designs of current hair implants deep in thegalea aponeurotica, with no escape or discharge mechanism), involvingthe epidermal and dermal layers. The more superficial inflammation willmost likely result in the formation of a pimple type structure with thesubsequent discharge of pus and the fragments, not unlike the typicalpimple formation found in certain conditions such as acne.

Implantation Technique

Introduction

The preferred implantation technique involves several steps includingpre-treatment with antibiotics and anti-inflammatories, recipient skinsite preparation, anesthesia, recipient site formation, hair implantselection and placement, temporary hair implant stabilization and skinclosure by medical glue, artistic concerns, and post procedure care withantibiotics, corticosteroids, and instruction regarding the propercleansing of the scalp.

Natural Look of Hair Exiting the Scalp

The administration of antibiotics and anti-inflammatory medications andrecipient site anti-bacterial preparation are very important first stepsin the process. Considering that potentially thousands of hair implantswill be placed, with the corresponding thousands of needle pokes intothe skin, it is prudent to begin medical therapy to prevent infectionand a hyperinflammatory response. Infection or a hyperinflammatoryreaction may result in skin surface or epidermal and/or dermal skindamage. This damage may translate into a pitting effect, or visibleindentations where the recipient site and subsequent hair implant wereplaced. This type of imperfection will draw attention to the scalp,especially under certain lighting which will accentuate this pittinglook.

Recipient skin site preparation involves washing the designated skinarea with soap and water, then betadine or an acceptable surgicalcleansing solution is applied, then, after the cleansing solution dries,it is wiped off with sterile alcohol. This sequence of skin cleansing,with the appropriate donning of staff in addition to having thetreatment room air purity level at an ISO 4 or 5, will eliminate orsignificantly reduce any bacteria or spores in the field of operation.

Recipient site formation is another critical step not only to form ahole for the hair implant, but to minimize the actual puncture (e.g., byan appropriately sized needle) or cut size (e.g., by an appropriatelysized scalpel) which will minimize the healing needed and potentialvisible signs of skin pitting. In addition, the site formed needs toparallel the natural angle that hair would normally exit. This willallow for the hair to fall naturally forward, to the side or backaccording to the patient's natural angulation and thus natural hairstyle look. The actual process of recipient site formation involves avery similar technique currently used in surgical hair transplantprocedures. The recipient site formation technique involves using a22-32-gauge sterile needle, a size 11 or 15 blade or similar instrument.The needle is used to poke the scalp at a very specific angle and depth,depending on what hair pattern and density is desired. For example, ifthe patient desires to fill in the scalp crown area with hair implants,it will be observed that a ‘whirl’ pattern naturally exists there.Considering this, the needle used to poke the skin in this scalp areawill need to emulate this type of ‘whirl’ pattern. This is accomplishedby poking the needle at an acute angle to the scalp and with a rotatingtype pattern. Then, when the hair implants are placed in, they willstick out of the scalp in a whirl pattern. The depth of the needle pokeneeds to approximate the normal follicular depth of 6 mm (in this caseof scalp hair placement). If eyebrow hair is going to be placed in, theneedle pokes need to be more superficial, about 3-4 mm deep, etc.Lastly, the needle poke incisions will be placed as close together aspossible. Considering that an inflammatory reaction is a normal responseto a needle poke and foreign body reaction to the silicone tipped hairimplant, it is advisable to space out the implants by 3-4 mm, andproceed with subsequent implants in the same manner over 3-4 treatmentsto ultimately fill in the skin area to the desired density.

Hair implant selection is very important to maintain a natural look. Forexample, the hairline on the scalp has thinner hair fiber diameters thanhairs just 1.25 cm behind it. This transition of finer to more coarsehair is common and is what is natural. The selection of thinner fiberdiameter hairs will need to be selected for the hairline areas to mimicthe natural.

The silicone tipped portion of the hair implant is surgically placedwith an approximate depth of 3-6 mm under the skin depending on whetherscalp, pubic, or other body hair is being restored. This silicone tippedportion of the hair will not impair the natural look of the hair implantbecause the clear type of silicone used will be invisible to the eye andwill remain mostly under the skin, with a small 0.1 to 0.5 mm segmentremaining above the skin (or below in certain embodiments), keeping itout of view.

Hair Implant Placement

Appropriate anesthesia allows for the proper placement of the hairimplants with the proper depth placement. Anesthesia involves theapplication of a topical cream lidocaine type anesthetic on therecipient site, or area of skin that will receive the hair implants.After 30 minutes of topical anesthetic application, the area is cleanedand then an injectable form of tumescent lidocaine anesthetic solutionis administered in a field block manner. The anesthetic cream isadministered after the area is cleaned with soap and water, then theanesthetic is removed, wiped down with sterile alcohol, then the area isinjected with a tumescent solution of lidocaine, then the betadine orother type solution is administered, etc.

In those embodiments wherein the hair is added to the anchor at aphysician's office, at a hair implantation clinic, or at a manufacturerwith or without an automated process, the hair implant placement firstinvolves opening a sterile pack of either the anchor portion of theimplant only, which will need subsequent attachment of the haircomponent, or the anchor portion with the hair already attached. If thesterile pack only has the anchor component, then the pack will be openedat the physician's office or clinic, and the anchors will be placed ontoa sterile tray. Hair components are then added to the anchors. There areseveral methods of hair to anchor attachment with several exemplaryembodiments discussed below.

After the hair has been attached to the anchor it is ready for placementinto the skin. A fine jeweler type sterile tweezer can be used to pickup the hair implant by the silicone tipped area and insert it into therecipient site hole made by the needle. After all of the hair implantshave been placed into position, the technician places a tiny drop ofmedical adhesive (e.g., cyanoacrylate or another fast drying medicalglue) to immediately stabilize the hair implant. This technique, withthe fine instruments used, will minimize trauma and heal better andresult in a more natural skin surface.

Hair Density and Hair Pattern

The hair implant technique, using very close recipient site placement,recipient site with appropriate angulation, the use of delicatejeweler's forceps, and a glue down technique to stabilize the hairimplant, will allow for high dense packing and appropriate hair pattern.

Providing close approximation of recipient sites, with very small needlecuts to puncture the scalp, will allow for more density per hair implantsession. The angle by which the recipient site is made is critical tothe hair pattern formed. For example, if one wants to have a naturalwhirl pattern on the crown of the scalp, a very deliberate rotatingangulation pattern will need to be prepared to emulate a natural hairpattern.

The use of fine and delicate jeweler's forceps is important in thehandling and proper placement of the hair implant itself. The jeweler'sforceps allows for a gentle hold on the implant, preventing damage, andallows an unobstructed view of the placement of the implant into thescalp, due to the forceps holding only a small portion of the distalportion of the implant without obstructing a direct view of the proximalend of the implant for easy placement into the recipient site.

The final glue down of the hair implant will immediately stabilize andtemporarily anchor the implant and prevent premature pull out. Since theforeign body reaction and anchoring of the hair implant takes 14-21days, this temporary anchoring mechanism will prevent hair fall out anda reduction in hair density.

FIG. 8 is schematic top view of a plan for the placement in the scalp ofimplants 20 comprising vertical components 24, distal ends 34, distalorifices 32 and hairs 28. Overlaying the scalp is a 10×10 grid whereineach cell of the grid represents a 1 mm×1 mm area of the scalp. Eachimplant 20 occupies two cells in the embodiment of FIG. 8. Completion ofthis placement scheme would result in fifty implants (or follicularunits) per cm², or one-hundred hairs per cm² when the follicular unitshave two hairs each.

Anchoring of the Hair Implant

The recipient site, being a surgical step by poking a needle into theskin, is the key method of allowing the hair implant access andapproximation to the living tissue and the very important immune systemreaction. This hair implant and skin issue approximation will allow forthe foreign body reaction and all the anchoring effects to occur (seethe anchoring section above).

The final glue down of the hair implant will immediately stabilize andtemporarily anchor the implant and prevent premature pull out. Since theforeign body reaction and anchoring of the hair implant takes 14-21days, this temporary anchoring mechanism will prevent hair fall out.

Protecting the Hair Implant from the Immune System

The recipient site, being a surgical step by poking a needle into theskin, is the key method of allowing the hair implant access andapproximation to the living tissue and the very important immune systemreaction. This hair implant and skin tissue approximation will allow forthe foreign body reaction to take place and form the collagen envelope.After the collagen envelope has completely formed, the foreign bodyreaction has completed its objective to protect the body by entombingthe “foreign body” with this thick collagen shell and will thenterminate the immune system reaction. This collagen shell provides dualprotection, protecting the implant from further immune system reactions,and protects the body from the implant harming the body (foreign bodyreaction assumes the foreign body is dangerous and thus walls it off toprotect the body).

Hair Implant Safety Features

With appropriate antiseptic cleansing of the skin, utilizing sterileinstruments for anesthesia, recipient site formation, and hair implantplacement, hair implant stabilization, and immediate glue sealing of theepidermal incision site, will limit bacterial entrance in the shortterm. Long term safety features of forming a bacterial barrier,anchoring, and fracture and fragment retention issues are discussedabove.

This implantation technique will allow for complete removal in certainembodiments, if desired. The hair implant is placed into the scalp asdeeply as natural hair fibers are in the scalp, about 5-6 millimetersdeep (only into the subcutaneous/dermal areas where normal natural hairresides). The term “subcutaneous” as used herein is defined in itsbroadest sense as encompassing the epidermal, intradermal, andsubcutaneous spaces, including adipose tissue. If the hair implant needsto be removed, this can be done by a simple plucking motion (likeplucking out normal hair). So to remove the hair is a safety factor justin case there is a follicle that becomes infected. It is normal fornatural hair follicles to sometimes become infected, so it follows thatthe same risk applies to the inventive hair implant.

Infection and inflammation of hair bearing skin is not uncommon. Manypeople naturally develop low level folliculitis or inflammation of thehair follicles. This can be due to a multitude of causes includingbacterial and non-bacterial sources, ingrown hairs, poor hygiene, hairfall out and regrowth, etc. Some other causes of infection andinflammation are from simple shaving, others from hormonal issues, oreven from the natural bacteria found in the hair follicular and skinareas. Even though infection and inflammation is found naturally, andtypically at minor levels, the goal of hair implantation is to improveupon what is observed as the natural occurrence of hair bearing skininfections and inflammation.

It is projected that the incidence of skin infections and inflammationassociated with the inventive implants will be less than that foundnaturally. The lack of glandular organs and their secretions will makethe implant area less conducive to bacterial growth. In addition, theanchor of the invention has no hormone receptors to trigger aninflammatory response, unlike natural hair follicles.

Manufacturing of Implants

The anchor of the inventive implant can be formed by a variety ofdifferent processes, including by injection molding and 3-D printing.The anchor preferably comprises a material selected for certaincharacteristics such as the appropriate durometer, molecular weight,crosslinking, and strength. These characteristics will not only helpprovide the appropriate strength to withstand oxidation and fracturing,but will easily withstand the pressure forces of the tweezerimplantation technique. This aspect of tweezer placement is significantmainly in hair transplant surgery when working with live hair follicularunits. Tweezer placement can traumatize and crush living hair follicles,but in the case of hair implants that, of course, is not a risk.

Materials highly resistant to long term chemical interaction with theimmune system are preferred. High implant strength longevity isdesirable. If the hair is physically pulled out the goal is for theentire implant unit to be ejected in one or two parts, thus preventingbreakage (other than at the fracture line) and remnants of the implantto remain under the skin.

Medical grade silicone is the most preferred material for forming theanchor. Other materials suitable for use in forming the anchor includebut are not limited to metals (including but not limited to preciousmetals, metalloids, and other metals), biocompatible polymers (includingbut not limited to silicones, silicone elastomers, acrylic and otherresins, plastics, polyethylene, PTFE, polyesters, PVC, PMMA, hydrogels,etc.), ceramics (including but not limited to silicates, glass,porcelains, carbons, etc.), natural biomaterials (including bone,calcium phosphate based, etc.), and any combination thereof (definedherein as composites).

In a preferred embodiment, implantable medical grade silicone is usedfor implant production. The silicone material is typically in a liquidform and in two parts. Upon mixing the two parts, part A and part B, achemical reaction will occur and cause a silicone rubber to be formed.This liquid to solid reaction can be controlled by keeping the mixturecold to slow down the liquid to solid reaction and allow time to injectthe liquid silicone into the mold. After being injected into the mold,heat is applied to complete the liquid to solid formation reaction.

The mold preferably comprises a multitude of cavities for receiving theliquid to be solidified to form the anchors of the implants. The numberof cavities is not particularly limited, and in certain embodiments canrange from 1 or 10 or 100 or 1,000 or 10,000 cavities to 10 or 100 or1,000 or 10,000 or 100,000 cavities per mold.

The dimensions of a cavity are dictated by the desired dimensions of theresulting implant. In certain embodiments, the cavities are 1-10 mm or3-9 mm or 5-7 mm or 6 mm deep with a maximum diameter of 0.2-1.2 mm or0.4-1.0 mm or 0.6-0.8 mm or 7.0 mm.

The fluid in the cavities should preferably be free of air bubbles,voids and the like. In certain embodiments, the anchor mold comprisestwo plates which are used in a process that minimizes or avoids airbubbles—a first plate having a plurality of holes through it and asecond plate that closes off the holes in the first plate. The twoplates are immersed in silicone liquid with the second plate being usedto force the silicone liquid through the holes in the first plate (likea plunger on a syringe) until the two plates are in contact with eachother. The excess silicone fluid is then scraped off the surface of thefirst plate to provide a mold having a plurality of cavities filled withsubstantially bubble-free liquid silicone.

In unitary hair implants of the invention, hair strands are formed withor as a portion of the anchor body using, e.g., molds including anchorbody and hair and/or by drawing filaments from the anchor body while itis still in an uncured state.

In non-unitary embodiments, the strands of hair to be inserted in theanchors are preferably pre-coated with silicone (or other bonding agentor primer compatible with silicone, such as alkoxy silane monomers orpolymers as taught by U.S. Pat. No. 5,061,284 (117)) to a length of,e.g., 2-10 mm or 6-8 mm or 7 mm and then allowed to form a solid. Thelength of this coating applied to the hair strands is preferablyselected to be 1 mm longer than the depth of the anchors in which thehair strands will be placed, such that the coating extends 1 mm abovethe anchor and remains external to the surface of the epidermis afterimplantation. In other embodiments, the length of the coating is 0.1 or0.5 mm to 1.5 or 2 mm longer than the anchor depth.

After the hair strand coating has dried to form a solid, the hairstrands are placed into the silicone liquid filled mold cavities. Eachmold cavity can receive 1, 2, 3, 4 or more hair strands. The mold isthen heated to solidify the silicone to form implants having one or morehairs each. The implants are then removed from the mold, sterilized andpackaged for distribution and use.

In certain embodiments, the hair will be inserted and then anchored byseveral potential mechanisms.

In a preferred embodiment of a distal to proximal insertion method, glueis applied to approximately 6 mm of the proximal end of the hair and isthen fed into the distal orifice of the internal hair chamber until itreaches the proximal closure of the internal hair chamber.

In a first preferred embodiment of a proximal to distal insertionmethod, the hair will not be glued first but will first be inserted intothe proximal orifice of the vertical component hair chamber, then thehair is pushed through until only 6 mm of the proximal end is visible,then glue is added to this 6 mm end, and finally the hair is continuedto be pulled through until completely in the hair chamber.

In a second preferred embodiment of a proximal to distal insertionmethod, the hair will not be glued first but will first be knotted atits proximal end, and then fed into the proximal opening of the knotchamber until only about 6 mm of the proximal end of the hair isvisible. Glue is then applied to this 6 mm end (which will contain theknots), and then the hair is continued to be fed through the hairchamber until reaches the most distal end of the knot chamber.

It is preferred that the hair chamber opening through which the hairwill be inserted have a conical shape so as to facilitate hair insertionby the technician (or if automated, by a machine) and to allow a greateramount of glue to remain at that location for increased adhesion.

The knot chamber is an enlarged proximal end of the hair chamberconfigured to receive the knotted hair portion which has a greaterdiameter than the unknotted portion of the hair shaft. The hair chamberdistal to the knot chamber has a narrower diameter than the knot chambersuch that the knotted hair is too wide to leave the knot chamber andenter the hair chamber. The diameter of the knot chamber is preferably500-600 microns, and the length of the knot chamber is preferably from500 microns to 6 mm.

In certain embodiments, the vertical component will have a proximalouter surface end which will be rounded. The arc will be 180 degrees,and the circle diameter will be 500 microns to 2 mm. If there is an ovalshape, the largest dimensions of the oval will be the same.

It is preferred that at least some and more preferably all edges of theanchor are rounded. This includes the embodiments depicted in thefigures.

There are many types of hairs on the body including scalp, facial,eyebrow, arm and leg, pubic, eyelash, etc., and the manufacturingprocess can be modified to produce the appropriate hair implants for theskin area in question. Thus, for example, eyebrow hair implants will besmaller than scalp hair implants.

In an alternative embodiment, final assembly of hair implants isperformed by the end user (physician, physician's assistant, hairtechnician, etc.). Sterile anchors are supplied to the user, who selectsappropriate hair for a given patient and procedure and bonds the hair tothe anchors prior to implantation, using, e.g., an adhesive suitable forbonding hair (or synthetic hair) to the anchor material. Suitableadhesives included but are not limited to cyanoacrylates.

As discussed above, the exit angle of hair strands from the anchor ispreferably varied for different implantation locations. Thus, theplacement of hair strands in the mold cavities can be varied to provideimplants with hair exit angles ranging from 1-90°. It is also possibleto use curved, angled or otherwise non-linear hair strands in themanufacturing process to achieve the same or similar effect. Thus, forexample, a hair stand having a 100° angle 5 mm from its proximal end canbe inserted in a 6 mm deep mold cavity such that the hair strand exitsthe resulting anchor at a 10° angle to the surface.

While the invention has been described in detail and with reference tospecific examples thereof, it will be apparent to one skilled in the artthat various changes and modifications can be made therein withoutdeparting from the spirit and scope thereof.

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REFERENCE NUMBERS

-   -   20. Implant    -   22. Anchor    -   22A. Cruciform-Shaped Anchor    -   22B. Inverted “Y”-Shaped Anchor    -   22C. Barbed Anchor    -   22D. Racket-Shaped Anchor    -   22E. Bar-shaped Anchor    -   22F. Ovoid-shaped Anchor    -   22G. Screw-shaped Anchor    -   24. Vertical Component or Anchor Body    -   24A. Hair Element Arm    -   24B. Anchor Arm    -   24C. Ovoid Anchor Body    -   26. Bridge    -   27. Connecting surface 27A and 27B    -   28. Hair or Hair Element    -   30. Internal Hair Chamber    -   32. Distal Orifice    -   34. Distal End    -   34A. Upper Surface    -   34B. Curved Distal Surface    -   36. Proximal Orifice    -   38. Proximal Closure of Internal Hair Chamber    -   40. Proximal End    -   40A. Proximal End    -   40B. Proximal End    -   42. Closed Tunnel (or Closed Void)    -   42A. Closed Tunnel (or Closed Void)    -   42B. Closed Tunnel (or Closed Void)    -   43. Central Point    -   44. Open Tunnel (or Open Void)    -   46. Fracture Line    -   48. Knot Chamber    -   50. Knot    -   52. Concavity    -   54. Proximal Bulbous Shape    -   56. Epidermis    -   58. Dermis    -   60. Follicular Unit    -   62. Follicle    -   64. Scalp    -   66. Undulation    -   68. Rounded Indentation    -   70. Protrusion    -   71. Cup-shaped structure    -   72. Convexity    -   74. Horizontal Component or Anchor Body    -   76. Thread    -   78. Hair Bundle    -   80. Ancillary Hair Element    -   82. Hair Bud Structure    -   84. Implant Anchor    -   86. Cylindrical Shape    -   88. Top Portion    -   90. Larger Diameter    -   92. Smaller Diameter    -   94. Hair Chambers    -   96. Hair    -   98. Distal Orifice    -   100. Distal Surface    -   102. Closed Tunnel    -   104. Open Tunnel    -   106. Implant Anchor    -   108. Cylindrical Shape    -   110. Top Portion    -   112. Larger Diameter    -   114. Smaller Diameter    -   116. Hair Chamber    -   118. Hair    -   120. Distal Orifice    -   122. Distal Surface    -   124. Closed Tunnel    -   126. Open Tunnel    -   128. Column    -   130. Base Portion    -   132. Top of Base Portion    -   134. Bottom of Base Portion    -   136. Implant Anchor    -   138. Hair Chamber    -   140. Implant Anchor    -   142. Rectangular Solid    -   144. Hair    -   146. Distal End    -   148. Closed Tunnel    -   150. Open Tunnel    -   152. Column    -   154. Base Portion    -   156. Flat Sides    -   158. Edges

What is claimed is:
 1. A hair implant suitable for subcutaneousimplantation, comprising: (a) an anchor comprising: (i) an anchor bodywherein the anchor body is generally a rectangular solid in shape; and(ii) at least one collagen receiving structure selected from the groupconsisting of at least one tunnel disposed through the anchor body; and(b) at least one hair strand projecting from a distal end of the anchorbody, wherein the at least one collagen receiving structure isconfigured to support collagen ligature growth after subcutaneousimplantation of the hair implant so as to anchor the anchor to a hairimplant recipient, and the collagen receiving structure is free of hair.2. The hair implant of claim 1, including a bulbous, base portion havingflat sides and edges having smoothly rounded radii.
 3. The hair implantof claim 1, wherein the anchor body comprises two vertical columns ofclosed tunnels and a pair of open tunnels at a bottom of the anchorbody.
 4. The hair implant of claim 2, wherein the anchor body comprisestwo vertical columns of closed tunnels and a pair of open tunnels at abottom of the anchor body.
 5. The hair implant of claim 1 wherein theanchor body comprises a fracture line that runs vertically from aproximal end of said anchor body to said distal end of said anchor body.